• Tiada Hasil Ditemukan

EVALUATION OF THE PSYCHOLOGICAL

N/A
N/A
Protected

Academic year: 2022

Share "EVALUATION OF THE PSYCHOLOGICAL "

Copied!
135
0
0

Tekspenuh

(1)

EVALUATION OF THE PSYCHOLOGICAL

EFFECT AND VISION RELATED QUALITY OF LIFE IN ENUCLEATED/EVISCERATED

PATIENTS WITH PROSTHETIC EYES

by

DR JEYARINE MONICA JOAN POOBAL ROYAN

Dissertation Submitted in Partial Fulfilment of the Requirement for the Degree Of

MASTER OF MEDICINE (OPHTHALMOLOGY)

SCHOOL OF MEDICAL SCIENCES UNIVERSITI SAINS MALAYSIA

2018

(2)

II DISCLAIMER

I hereby certify that the work in this is my own except for the quotations and summaries which have been duly acknowledged.

Date: 30 MAY 2018 ………..………

Dr Jeyarine Monica Joan Poobal Royan P-UM0 130/14

(3)

III ACKNOWLEDGEMENT

First and foremost, I would like to acknowledge and thank my supervisor Dr Khairy Shamel Sonny Teo for his continuous support, patience and guidance throughout these past few years, and particularly while I embarked into this journey of research for the first time.

I would also like to thank my two other supervisors, Dr Ong Poh Yan & Associate Professor Dr Asrenee Ab Razak for their invaluable input, suggestions and support during this time.

I thank all the patients who participated in this study, and for giving me their precious time and patience whilst I conducted this research.

I would like to especially acknowledge my friends and colleagues for always supporting me and encouraging me.I also thank my wonderful parents and siblings for always being by my side, and for always keeping my spirits up at the toughest times.

To my husband Kumaresan, who has been my best friend and partner through everything; I thank you from the bottom of my heart for all your support, friendship, patience and encouragement and for always believing in me.

(4)

IV TABLE OF CONTENTS

TITLE I

DISCLAIMER II

ACKNOWLEDGEMENT III

TABLE OF CONTENTS III

ABSTRAK (BAHASA MELAYU) VI

ABSTRACT (ENGLISH) ERROR! BOOKMARK NOT DEFINED.

CHAPTER 1: INTRODUCTION 1

1.1ANOPHTHALMIA 2

1.2.1EVISCERATION 3

1.2.2ENUCLEATION 4

1.3PROSTHETICEYES 5

1.4ANXIETYANDDEPRESSION 7

1.5QUALITYOFLIFE 8

1.6RATIONALEOFSTUDY 10

1.7REFERENCES 12

CHAPTER 2: OBJECTIVES OF THE STUDY 18

2.0STUDYOBJECTIVES 19

2.1GENERALOBJECTIVES 19

2.2SPECIFICOBJECTIVES 19

CHAPTER 3: MANUSCRIPT 20

3.1ABSTRACT 23

3.2BACKGROUND 24

3.3METHODS 29

3.4RESULTS 31

3.4.1Demographic results 31

3.4.2 Mean NEI-VFQ Scores & Mean HADS (D) and HADS(A) scores 32 3.4.3 Variables associated with vision related quality of life 32

3.4.4 Variables associated with Depression 32

3.4.5 Variables associated with Anxiety 33

3.5DISCUSSION 34

3.6CONCLUSION 38

3.7DECLARATIONS 38

3.7.1 Ethics approval and consent to participate 39

3.7.2 Consent for publication 39

(5)

V

3.7.3 Availability of data and materials 39

3.7.4 Competing interests 39

3.7.5 Funding 39

3.7.6 Authors’ contributions 39

3.7.7 Acknowledgments 40

3.8REFERENCES 40

3.9TABLESANDFIGURES 43

3.10SUBMISSIONGUIDELINE 48

CHAPTER 4: STUDY PROTOCOL 56

4.0INTRODUCTION 58

4.1LITERATUREREVIEW 60

4.2RATIONALEOFSTUDY 64

4.3RESEARCHOBJECTIVE 64

4.3.1 General Objective 64

4.3.2 Specific Objectives 64

4.4RESEARCHHYPOTHESIS 65

4.5METHODOLOGY 65

4.5.1 Study Design 65

4.5.2 Study Location 65

4.5.3 Study Duration 65

4.5.4 Study Population 65

4.5.5 Source Population 65

4.5.6 Sampling Frame 66

4.5.7 Inclusion & Exclusion &Withdrawal Criteria 66

4.5.8 Sample Size Calculation 67

4.5.9 Sampling Method 69

4.6RESEARCHTOOLS 69

4.6.1Hospital Anxiety and Depression Scale (HADS) questionnaire 69 4.6.2 National Eye Institute Visual Functioning Questionnaire 25(VFQ-25

questionnaire) 70

4.7DATACOLLECTIONPROCEDURE 73

4.8STATISTICALANDDATAANALYSIS 74

4.9EXAMINATIONPROCEDURE 74

4.10OPERATIONALDEFINITIONS 75

4.10.1 Anxiety and depression 75

4.10.2 Quality of life 76

4.10.3 Prosthetic eyes 76

4.10.4 Highest education 77

4.10.5 Monthly Household Income 77

4.11ETHICALCONSIDERATIONS 78

4.11.1 Privacy and Data Confidentiality 78

4.11.2 Publication Policy 79

(6)

VI

4.11.3 Subject Vulnerability 79

4.11.4 Risks and Benefits 80

4.12FLOWCHART 81

4.13DUMMYTABLES 82

4.14REFERENCES 86

4.15APPENDICES 89

4.15.1 Gantt Chart 89

4.15.2 Demographic Questionnaire Form 90

4.15.3 The National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)

(Interviewer Format) 92

4.15.4 Appendix D: Borang Soal Selidik The National Eye Institute VFQ-25 versi

Bahasa Melayu (Formal Temu Bual) 99

4.15.5 The Hospital Anxiety and Depression Scale (HADS) (English version) 105 4.15.6 Hospital Anxiety and Depression Scale (Malay Version) 106

4.15.7 Ethical approval letters 107

CHAPTER 5: APPENDICES 113

5.1INFORMATIONANDCONSENTFORM 114

5.2DATAINFORMATIONSHEET 121

5.3RAWDATAFORSPSS 122

(7)

VII ABSTRAK

Pengenalan:

Pesakit yang anoftalmia selepas pembedahan evisceration atau enucleation diwawancara tentang kehilangan mata dan juga proses patologi yang menyebabkan pembedahan dilakukan.

Mata prostetik telah membantu pesakit untuk mendapat kesan kosmetik yang lebih baik selepas pembedahan. Pesakit anophthalmia mungkin mempunyai kesan psikologi yang tidak dikenal pasti oleh doktor yang merawat mereka. Oleh itu, mengenal pasti kesan psikologi tersebut adalah penting untuk membantu pesakit agar mereka boleh dirujuk kepada mereka yang berkenaan.

Objektif:

Tujuan utama kajian ini dilakukan adalah untuk menilai tahap kebimbangan, tekanan perasaan dan kualiti hidup pesakit dengan mata prostetik selepas pembedahan evisceration atau enucleation dan untuk menentukan peramal yang berpotensi berkaitan dengan masalah tersebut.

Kaedah:

Satu kajian keratan lintang telah dijalankan diantara Mac 2017 dan Mac 2018 melibatkan pesakit-pesakit yang menggunakan mata prostetik selepas pembedahan evisceration atau enucleation yang datang ke klinik mata dia dua hospital rujukan di Malaysia, Hospital Selayang dan Hospital Universiti Sains Malaysia. Pesakit-pesakit ini telah diberikan dua set soal selidik yang telah disahkan: The National Eye Institute Visual Functions Questionnaire – (NEI-VFQ) dan Hospital Anxiety and Depression (HADS). Selepas soal selidik

(8)

VIII dilengkapkan, skor dijumlahkan dan dikira. Analisis statistik dilakukan menggunakan Statistic Package for the Social Science (SPSS Inc Versi 22).

Keputusan:

Seramai 54 orang pesakit telah mengambil bahagian dalam kajian ini. Pelbagai demografi dan pemboleh ubah klinikal yang telah diuji ataranya umur, jantina, bangsa, status perkahwinan, tahap pendidikan tertinggi, pendapatan bulanan, sebab pembedahan dan tempoh pemakaian mata prostetik. Purata komposit kualiti kehidupan berkaitan dengan visual berjumlah 75.97. Skor minimum adalah 18.75 dan skor maksimum adalah 100.

Purata skor bagi HADS (D) tekanan perasaan, adalah 1.94 dengan julat skor antara 0 sehingga 8. Seramai 53 pesakit telah memberikan skor normal dan seorang memberikan skor melebihi 8. Purata skor HADS (A) kebimbangan, adalah 3.61 dengan julat skor antara 0 sehingga 10. Seramai 48 pesakit memberikan skor normal dan 6 pesakit memberikan skor melebihi 8, dimana skor 8 mewakili kebimbangan/tekanan yang ringan. Tiada kaitan yang bererti diantara pemboleh ubah demogafi dan klinikal dengan kualiti hidup berkaitan visual dan tahap tekanan perasaan berdasarkan formula regrasi linear mudah dan berganda (p> 0.05 bagi semua pemboleh ubah yang diuji). Terdapat kaitan yang bererti diantara pemboleh ubah demografi dan tahap kebimbangan di mana p< 0.05 bagi umur, jantina perempuan, tempoh pemakaian mata palsu dan anoftalmia disebabkan oleh trauma. Skor kebimbangan berkurangan dengan setiap tahun peningkatan umur pesakit setiap tahun. Secara purata pesakit wanita mempunyai 1.49 mata lebih tinggi bagi skor kebimbangan berbanding pesakit lelaki. Pesakit yang telah memakai prosthesis melebihi 5 tahun memperoleh skor kebimbangan yang lebih rendah berbanding dengan pesakit yang baru setahun menggunakannya. Pesakit anoftalmia daripada punca trauma memperoleh skor kebimbangan

(9)

IX yang lebih tinggi berbanding mereka yang anoftalmia yang berpunca daripada tumor, jangkitan atau mata buta yang sakit.

Kesimpulan:

Kajian ini mendapati purata kualiti kehidupan pesakit berkaitan visual bagi pesakit dengan mata palsu selepas pembedahan evisceration/enucleation adalah berkurangan. Walau bagaimanapun, purata skor kebimbangan dan tekanan perasaan dikalangan pesakit ini adalah normal.

Tiada peramal yang berpotensi bagi kualiti kehidupan berkaitan visual atau tekanan perasaan.

Peramal bagi tahap kebimbangan dikalangan pesakit anoftalmia dengan mata palsu yang berpotensi adalah jantina, umur, tempoh penggunaan mata palsu, trauma danpunca anoftalmia.

(10)

X ABSTRACT

Introduction:

Patients with acquired anophthalmia post evisceration or enucleation surgeries are confronted with the loss of an eye as well as the pathological process which led to the surgery being performed. The regular use of prosthetic eyes in these patients has helped them to achieve a reasonable cosmetic outcome post operatively. Psychological sequelae of anopthalmia and prosthetic eye wear is often not addressed by the treating physician. Thus, identification of such sequelae may be helpful to these patients and others in the future so that they may referred to the appropriate channels for further evaluation.

Objective:

The aim of our study was to evaluate the levels of anxiety, depression and vision related quality of life in patients with prosthetic eyes post evisceration or enucleation and to determine the potential predictors associated with it.

Methods:

A cross sectional study was conducted between March 2017 and March 2018 involving patients with prosthetic eyes post evisceration or enucleation attending eye clinics of two tertiary hospitals in Malaysia; Hospital Selayang and Hospital Universiti Sains Malaysia.The patients were given two validated questionnaires: The National Eye Institute Visual Function

(11)

XI Questionnaire – (NEI-VFQ) and the Hospital Anxiety and Depression (HADS) questionnaire.

After completion, the questionnaires were calculated and scored, and statistical analysis was done using Statistical Package for the Social Science (SPSS Inc Version 22).

Results:

A total of 54 patients with acquired anophthalmia with prosthetic eyes participated in the study. The demographic and clinical variables that were assessed were age, gender, race, marital status, highest education level, monthly household income, reason for enucleation/evisceration and duration of prosthesis wear.

The mean composite visual related quality of life was reduced with a score of 75.97. The minimum composite score was 18.75 and the maximum composite score was 100.

The mean HADS (D) depression score was 1.94 with a range of scores from 0 to 8. 53 patients had normal scores and only one had a score of more than 8. The mean HADS(A) Anxiety score was 3.61 with a range of scores from 0-10.48 patients had normal scores, and 6 patients had scores of more than 8. A score of more than 8 represents mild depression or anxiety. There were no significant associations between the demographic and clinical variables with vision related quality of life and depression levels based on the simple and multiple linear regression formulas (p>0.05 for all variables tested). There were significant associations between demographic and clinical variables with increased anxiety levels where p<0.05 for the variables of younger age, female gender, reduced duration of prosthesis wear and anopthalmia secondary to trauma. Anxiety scores decreased with every 1-year increase in a patients’ age. Female patients had on average 1.49 points higher in anxiety scoring

(12)

XII compared to males. Patients with prolonged wear of prosthesis of more than 5 years had lower anxiety scores than those with less than 1 year of use. Patients with traumatic anophthalmia scored higher anxiety scores than those who acquired anophthalmia secondary to tumours, infections, or painful blind eyes.

Conclusion:

This study showed that the mean vision related quality of life scores in patients with prosthetic eyes post enucleation/evisceration was reduced however the mean anxiety and depression scores in these patients were within the normal range.

The predictors for increased anxiety levels in anophthalmic patients with prosthetic eyes was gender, age, duration of prosthesis wear, and the cause for anophthalmia. There were no potential predictors for vision related quality of life or for depression.

(13)

XIII

(14)

1

CHAPTER 1

INTRODUCTION

(15)

2 1.1 ANOPHTHALMIA

Anophthalmia is defined as the absence of the eye globe in the presence of ocular adnexa (lids, conjunctiva, lacrimal apparatus) which may be congential or acquired. (Verma and Fitzpatrick, 2007)

Congenital anophthalmia patients would present at birth or in childhood and is due to developmental anomalies which typically occurred in utero. Acquired anophthalmia may result either from evisceration or enucleations surgeries.

There are various indications for these destructive surgeries to be performed. Blinding ocular trauma which caused severe ocular damage and loss of ocular tissues which is irreparable, ocular malignancies requiring the eyeball to be removed to prevent further spread to surrounding structure, severe eye infections such as, panophthalmitis or endophthalmitis or perforated corneal ulcers which are not amenable to treatment and cases of painful blind eyes such as in neovascular glaucoma or pthyhsical eyes where there is loss of function are all common indications that warrant removal of the globe with or without surrounding structures.

The term ‘eye amputated’ has been coined to describe patients who have lost their eye following a surgery. (Rasmussen et al., 2010; Roed Rasmussen et al., 2009)

The decision to render a patient anophthalmic requires careful consideration and discussion between the physician and the patient as well as family members as it is a traumatic experience with potentially profound psychological sequelae.

After an evisceration or enucleation, a patient would have permanently lost the eye, some of their vision and a part of their face.(Rasmussen, 2010)

(16)

3 1.2.1 EVISCERATION

Evisceration is a surgical technique in which the intraocular contents are removed via a corneal, paralimbal or scleral incision. It is an ablative surgery. The contents that are removed include the retina, vitreous, lens and accessible uveal tissues, however the remaining sclera, Tenon’s capsule, conjunctiva, extra-ocular muscles, and the optic nerve and its surrounding meninges are still preserved.(Chen, 2001)

This procedure was first reported in 1817 and was later modified to include an orbital implant into the scleral shell. (Deborah, 1999; Limbu et al., 2009; Timothy et al., 2003)

Routinely, the surgery is completed by including the placement of an implant into the evisceration cavity to maintain appropriate orbital volume. This may help to prevent the development of contractures of the orbital socket which will enable the use of an appropriate artificial (prosthetic) eye that will be both comfortable to the patient and not visibly apparent to the public.(Leatherbarrow, 2002)

The indications for evisceration are usually for functional or cosmetic purposes. It is a simpler surgery than enucleation and involves less orbital manipulation.Postoperatively,there is expected to be better ocular movements and less chance of enophthalmos as compared with enucleation.(Hansen et al., 1999)

The ablative nature of the surgery consequently affects the anatomy and physiology of the orbital bones and orbital tissues which may affect cosmesis. A poor cosmetic result following surgery can have psychological implications for the patient the rest of their lives.(Odat et al., 2012)

(17)

4 1.2.2 ENUCLEATION

Enucleation is a surgical procedure that involves removal of the entire globe and its contents, while still preserving the surrounding periorbital and orbital structures such as the lids and ocular adnexae.

It was first reported in the 1500s and later there were reports of implant insertion post enucleation, with the objective of preserving the orbital volume and preventing contracture of the socket.(Sami et al., 2007)

The indications for performing enucleation are intraocular malignancy such as uveal melanoma or retinoblastoma, trauma, blind painful eyes, sympathetic ophthalmic and microphthalmos.

In cases of intraocular malignancy, enucleation is preferred as the intact globe and optic nerve can be sent for histological examination, and the margins of the tumour can be determined. It is also preferred in pthysical eyes as the shrunken scleral shell may not be able to accommodate an orbital implant if evisceration is performed.

It was found that there was no statistically significant aesthetic comparison between patients who underwent evisceration and enucleation, by both patients and masked observers.(Nakra et al., 2006) .The same study found that that postoperative implant motility is reduced in enucleation as compared to evisceration, but that prosthetic motility was comparable between both groups of patients.

(18)

5 1.3 PROSTHETIC EYES

An artificial eye or ocular prosthesis does not provide vision, unlike a functional visual prosthesis or bionic eye (neural prosthesis that partially restore lost vision or amplify residual vision). It assumes the shape of a convex shell and replaces an absent eye following destructive eye surgery, such as evisceration or enucleation.

Modern prosthetic eyes were first introduced in 1944 when Murphy and Nirronen created physiologic ocular prosthesis in the dental corps of the United States Navy during World War 2.(Beumer et al., 2011)

Prosthetic eyes are typically made of cryolite glass or medical grade plastic acrylic. They are available as readymade (stock) or custom-made prosthesis, the latter group more closely resembling the patients eye and being better fitted to the socket. Ocularists and occuloplastic surgeons usually manage the practice of fitting and managing prosthesis. Custom-made acrylic molds are molded based on the patient’s enucleated/eviscerated socket. The prosthesis is molded and then hand painted to closely resemble the fellow eye.

Stock prosthesis is readily available in a few standard sizes, shapes, and colors and are not specially molded to fit the socket. The advantage of the stock prosthesis is that it can be used in the interim or immediately post operatively, or whilst awaiting a custom-made prosthesis.

(Goel and Kumar, 1969; Kale et al., 2008; Reis et al., 2008; Smith, 1995)

(19)

6 Custom-made prosthetic eyes naturally are more superior to stock prosthesis as they allow for better ocular motility, have better fit and comfort, are less likely to cause ulceration and are able to adapt to the patients’ facial contours. There is also the obvious advantage of greater aesthetics as it is designed to look like the fellow eye in terms of the pupil and iris size as well as the colour of the iris and sclera. (Artopoulou et al., 2006; Beumer and Zlotolow, 1996; Ow and S, 1997). In addition, custom-made ocular prosthesis can provide close adaptation to the tissue bed whilst providing the wearer with maximum comfort and restoring the physiological function to the accessory organs of the eye.(Pun et al., 2016) They can provide excellent cosmesis if they are fitted properly.

Common complications of prosthetic eyes are conjunctival irritation and discharge, giant papillary conjunctivitis, poor fitting and poor mobility. (Pun et al., 2016)

In Malaysia, government hospitals provide services for ocular prosthesis; either by ocularists in certain centers with oculoplastic services, or by prosthodontic/dental departments. They are also available in certain private centers. In the government setting, both custom-made and stock prosthesis are provided free of charge. In private centers, one prosthetic eye can range from RM2800 to RM 7000.

The process of losing an eye has psychological effecst on a patient, hence a prosthesis should be provided as soon as possible for the comfort as well as psychological wellbeing of the patient.(Taylor, 2000)

(20)

7 Ideally, the psychological welfare of the patient should be evaluated prior to fitting and the nature of the ocular condition which led to the ablative procedure should be assessed, in the event of there being recurrence of the disease.(Cain, 1982)

1.4 ANXIETY AND DEPRESSION

Anxiety is a general term for several disorders that cause nervousness, fear, apprehension, and worrying. These disorders may manifest as physical symptoms and can also affect behavior and daily activities. The spectrum of anxiety may range from mild to severe which can severely debilitate a person and affect their daily activities.

Anxiety can be a normal response to a confronting a stressful situation, however if it begins to interfere and affect the individual’s ability to function or to sleep, it may be distressful for the individual.

It has been postulated that anxiety is a problem for people with facial disfigurement.

Macgregor described facial disfigurement as a ‘psychological and social death’.The affected individual anticipates negative reactions from others and may become shy and defensive thus leading to social anxiety,lowered self esteem and social avoidance.(Macgregor, 1990) Anxiety could influence how people react to situations.(Lazarus and Folkman, 1984).It could also result in reduced usage of functional coping mechanisms.(Dropkin, 2001)

Anxiety disorders can further be classified according into more specific types using the DSM- 5, the new edition of the Diagnostic and Statistical Manual of Mental Disorders. These

(21)

8 include common disorders such as General Anxiety Disorder, Panic Attacks and Panic Disorder.

Depression is one of the most common mental disorders worldwide.(Murray and Lopez, 1997) It is characterized as deterioration from previous function with the presence of psychological complaints such as depressed mood, loss of interest or pleasure, feelings of worthlessness or guilt and recurrent thoughts of death or suicide, together with somatic symptoms which include significant weight change, sleep disturbance, physical agitation or retardation, fatigue and inability to concentrate. (American Psychiatric Association, 2013) In a Malaysian study, it was found that the prevalence of depression in Malaysia varied from 3.9 to 46%.(Mukhtar and P. S. Oei, 2011)

The Hospital Anxiety and Depression Scale is a simple but useful screening tool which can help clinicians to detect various states of depression and anxiety in outpatient clinics. (Snaith, 2003; Zigmond and Snaith, 1983)

1.5 QUALITY OF LIFE

The term “Quality of life” (QOL) is defined by the World Health Organization (WHO) as the subjective perception of well-being and wholeness. It is a broad concept that is affected in a complex way by the person’s physical health, psychological state, and level of independence, social relationships, and their relationship with salient features of their environment.(Organization, 1947)

(22)

9 The assessment of health-related quality of life has been an important expansion of the assessment of the impact of disease and its treatment beyond the traditional areas of symptoms, signs, morbidity and mortality. It provides a more holistic assessment of the effects of disease on the person to include dimensions such as patient’s physical, social and emotional well-being.

Quality of life also has health economic implications; more precise knowledge of the impact on quality of life will help determine the level of disease at which the benefit of screening outweighs the cost.

Vision-related quality of life (VRQOL) is related to visual function though it is not identical to it. VRQOL illustrates the extent to which vision impactsa person’s ability to accomplish activities of daily living and encompasses an individual’s social, emotional and economic well-being. VRQOL can be assessed by measuring the degree of impairment experienced in activities of daily living that rely on sight.(Angeles-Han et al., 2011)

In adult patients, standardized visual function questionnaires in addition to clinical measures are used to assess visual disability using the National Eye Institute Visual Function Questionnaire – (NEI-VFQ).(Mangione et al., 2001).

(23)

10 1.6 RATIONALE OF STUDY

Previous studies have demonstrated that there is some level of anxiety and depression as well as a decreased vision related quality of life associated with having an ocular prosthesis.(Ahn and Lee, 2010; McBain et al., 2014; Ye et al., 2015).The major cause for this was due to the poorer vision related quality of life as well as due to concerns with facial appearance. Facial appearance was found to be an important factor on how they felt they are viewed by society at large and weather they felt discriminated.(McBain et al., 2014)

Poor Vision related quality of life in anophthalmic patients is associated with monocular vision causing difficulties in performing daily activities and working while as many as 26%

of patients reporting to having pain, which is a part of the phantom eye syndrome.(Ye et al., 2015)

The psychosocial and demographic variables were related to living arrangements (not living alone) and having adequate support from family and friends.(McBain et al., 2014) Other variables which had positive indicators were age, where younger ages were found to be more anxious as well as lower levels of education.(Ye et al., 2015).Conversely, in another study it was found that higher age, marriage and female gender were more associated with a greater negative impact on quality of life.(Song et al., 2006)

(24)

11 It was found that 29.9% and 28.4% of anophthalmic patients obtained a score ranging from 8- 21 on the HADS-A and HADS-D questionnaires respectively, which was comparable with the percentages seen in patients with other chronic diseases such as heart disease and cancer.(Ahn and Lee, 2010)

In the study by McBain et al, the HADS questionnaire was used as a screening tool to measure levels of anxiety and depression in patients with prosthetic eyes. The mean scores for both anxiety and depression were within the normal range, however 18% of patients were suffering from clinical anxiety and depression.(McBain et al., 2014)

In a study by Kondo et al., the NEI VFQ 25 as well as the Medical Outcomes Study Short Form 12, were used to assess vision and general health of anophthalmic patients as well as anxiety and depression.(Kondo et al., 2013)

Studies assessing the psychosocial impact of acquired anophthalmia and ocular prosthesis has been conducted in many countries. Vision related quality of life and levels of anxiety and depression in Malaysian patients with acquired anophthalmia and prosthetic eyes has not been assessed before. The psychosocial impact of ablative eye surgery and fitting with prosthetic eyes in Malaysian patients has not been considered or routinely assessed and followed up. There is a possibility that some patients may need counselling, behavioral therapy or a psychiatric referral which is being overlooked by ophthalmologists.

The rationale of this study is to investigate if there is indeed reduced vision related quality of life and increased levels of anxiety and depression and the demographic variables related to them, in the context of Malaysian patients with prosthetic eyes.

(25)

12 1.7 REFERENCES

Ahn, J. M. & Lee, S. Y. (2010). Health-Related Quality of Life and Emotional Status of Anophthalmic Patients in KoreaAm J Ophthalmology, 149.

Angeles-Han, S. T., Griffin, K. W., Harrison, M. J., Lehman, T. J., Leong, T., Robb, R. R., Shainberg, M., Ponder, L., Lenhart, P., Hutchinson, A., Srivastava, S. K., Prahalad, S., Lambert, S. R. & Drews-Botsch, C. (2011). Development of a vision-related quality of life instrument for children ages 8-18 years for use in juvenile idiopathic arthritis-associated uveitis. Arthritis Care Res (Hoboken), 63(9),1254-1261. doi: 10.1002/acr.20524

American Psychiatric Association, (2013). Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, D.C.: American Psychiatric Publishing

Artopoulou, II, Montgomery, P. C., Wesley, P. J. & Lemon, J. C. (2006). Digital imaging in the fabrication of ocular prostheses. J Prosthet Dent, 95(4),327-330. doi:

10.1016/j.prosdent.2006.01.018

Beumer, J., Curtis, T. & Marunick, M. (2011). Maxillofacial rehabilitation: prosthodontic and surgical considerations.In: 2nd ed.: St. Louis: Ishiyaku Euro America Inc.

(26)

13 Beumer, J. & Zlotolow, I. (1996). Restoration of facial defects.In: Beumer, J. (ed.), Maxillofacial Rehabilitation—Prosthodontic and Surgical Considerations: Mosby.

Cain, J. R. (1982). Custom ocular prosthetics. J Prosthet Dent, 48(6),690-694.

Chen, W. (2001). Evisceration.In: WP, C. (ed.), Oculoplastic surgery: The essentials: New York: Thieme, pp 347-355.

Deborah, D. (1999). History of enucleation and evisceration in ophthalmic surgery: principles and techniques.In: 2nd edition ed.: Blackwell, pp 1553-1562.

Dropkin, M. J. (2001). Anxiety, coping strategies, and coping behaviors in patients undergoing head and neck cancer surgery. Cancer Nurs, 24(2),143-148.

Goel, B. S. & Kumar, D. (1969). Evaluation of ocular prosthesis. J All India Ophthalmol Soc, 17(6),266-269.

Hansen, A. B., Petersen, C., Heegaard, S. & Prause, J. U. (1999). Review of 1028 bulbar eviscerations and enucleations. Changes in aetiology and frequency over a 20-year period.

Acta Ophthalmol Scand, 77(3),331-335.

Kale, E., Mese, A. & Izgi, A. D. (2008). A technique for fabrication of an interim ocular prosthesis. J Prosthodont, 17(8),654-661. doi: 10.1111/j.1532-849X.2008.00361.x

(27)

14 Kondo, T., Tillman, W. T., Schwartz, T. L., Linberg, J. V. & Odom, J. V. (2013). Health- related quality of life after surgical removal of an eye. Ophthalmic Plast Reconstr Surg, 29(1),51-56. doi: 10.1097/IOP.0b013e318275b754

Lazarus, R. S. & Folkman, S. (1984). Stress, Appraisal, and Coping. New York: Springer.

Leatherbarrow, B. (2002). Enucleation and evisceration.In: Leatherbarrow, B. (ed.), Oculoplastic surgery. London: Martin Dunitz, pp 305-317.

Limbu, B., Saiju, R. & Ruit, S. (2009). A retrospective study on the causes for evisceration at Tilganga Eye Centre. Kathmandu Univ Med J (KUMJ), 7(26),115-119.

Macgregor, F. C. (1990). Facial disfigurement: problems and management of social interaction and implications for mental health. Aesthetic Plast Surg, 14(4),249-257.

Mangione, C. M., Lee, P. P., Gutierrez, P. R., Spritzer, K., Berry, S., Hays, R. D. & National Eye Institute Visual Function Questionnaire Field Test, I. (2001). Development of the 25- item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol, 119(7),1050- 1058.

McBain, H. B., Ezra, D. G., Rose, G. E., Newman, S. P. & Appearance Research, C. (2014).

The psychosocial impact of living with an ocular prosthesis. Orbit, 33(1),39-44. doi:

10.3109/01676830.2013.851251

(28)

15 Mukhtar, F. & P. S. Oei, T. (2011). A Review on the Prevalence of Depression in Malaysia.

Current Psychiatry Reviews,, 7(3),234-238.

Murray, C. J. & Lopez, A. D. (1997). Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet, 349(9063),1436-1442. doi: 10.1016/S0140- 6736(96)07495-8

Nakra, T., Simon, G. J., Douglas, R. S., Schwarcz, R. M., McCann, J. D. & Goldberg, R. A.

(2006). Comparing outcomes of enucleation and evisceration. Ophthalmology, 113(12),2270- 2275. doi: 10.1016/j.ophtha.2006.06.021

Odat, T. A., Batayneh, I. M. & Al-Ghanam, S. A. (2012). Modified Evisceration Technique:

Post- EquatorialSclerectomy and Autogenous Scleral Patching Journal of the Royal Medical Services, 19(4),13-18.

Organization, W. H. (1947). The constitution of the World Health Organization. WHO Chron.

Ow, R. & S, A. (1997). Ocular prosthetics: use of a tissue conditioner material to modify a stock ocular prosthesis. Journal of Prosthetic Dentistry, 78(2),218-222.

Pun, S., Shakya, R., Adhikari, G., Parajuli, P., Singh, R. & Suwal, P. (2016). Custom Ocular Prosthesis for Enucleated Eye: A Case Report. Journal Of College Of Medical Sciences- Nepal, 12(3),127-130.

(29)

16 Rasmussen, M. L. (2010). The eye amputated - consequences of eye amputation with emphasis on clinical aspects, phantom eye syndrome and quality of life. Acta Ophthalmol, 88 Thesis 2,1-26. doi: 10.1111/j.1755-3768.2010.02039.x

Rasmussen, M. L., Prause, J. U., Johnson, M., Kamper-Jorgensen, F. & Toft, P. B. (2010).

Review of 345 eye amputations carried out in the period 1996-2003, at Rigshospitalet, Denmark. Acta Ophthalmol, 88(2),218-221. doi: 10.1111/j.1755-3768.2008.01435.x

Reis, R. C., Brito e Dias, R. & Mesquita Carvalho, J. C. (2008). Evaluation of iris color stability in ocular prosthesis. Braz Dent J, 19(4),370-374.

Roed Rasmussen, M. L., Prause, J. U., Johnson, M. & Toft, P. B. (2009). Phantom eye syndrome: types of visual hallucinations and related phenomena. Ophthalmic Plast Reconstr Surg, 25(5),390-393. doi: 10.1097/IOP.0b013e3181b54b06

Sami, D., Young, S. & Petersen, R. (2007). Perspective on orbital enucleation implants. Surv Ophthalmol, 52(3),244-265. doi: 10.1016/j.survophthal.2007.02.007

Smith, R. M. (1995). Relining an ocular prosthesis: a case report. J Prosthodont, 4(3),160- 163.

Snaith, R. P. (2003). The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes, 1,29. doi: 10.1186/1477-7525-1-29

(30)

17 Song, J. S., Oh, J. & Baek, S. H. (2006). A survey of satisfaction in anophthalmic patients wearing ocular prosthesis. Graefes Arch Clin Exp Ophthalmol, 244(3),330-335. doi:

10.1007/s00417-005-0037-0

Taylor, T. D. (2000). Clinical Maxillofacial Prosthetics (Vol. III). Chicago ,USA:

Quintessence.

Timothy, N. H., Freilich, D. E. & Linberg, J. V. (2003). Evisceration versus enucleation from the ocularist's perspective. Ophthalmic Plast Reconstr Surg, 19(6),417-420; discussion 420.

doi: 10.1097/01.IOP.0000096162.94415.98

Verma, A. S. & Fitzpatrick, D. R. (2007). Anophthalmia and microphthalmia. Orphanet J Rare Dis, 2,47. doi: 10.1186/1750-1172-2-47

Ye, J., Lou, L., Jin, K., Xu, Y., Ye, X., Moss, T. & McBain, H. (2015). Vision-Related Quality of Life and Appearance Concerns Are Associated with Anxiety and Depression after Eye Enucleation: A Cross-Sectional Study. PLoS One, 10(8),e0136460. doi:

10.1371/journal.pone.0136460

Zigmond, A. S. & Snaith, R. P. (1983). The hospital anxiety and depression scale. Acta Psychiatr Scand, 67(6),361-370.

(31)

18 .

CHAPTER 2

OBJECTIVES

OF THE STUDY

(32)

19 2.0 STUDY OBJECTIVES

2.1 GENERAL OBJECTIVES

To evaluate the psychological effect and vision related quality of life in enucleated/eviscerated patients with prosthetic eyes

2.2 SPECIFIC OBJECTIVES 2.2.1

To determine the mean NEIVFQ-25 scores in patients with prosthetic eye using a single mean formula in 2017-2018 in Hospital Selayang and Hospital Universiti Sains Malaysia 2.2.2

To determine the mean Anxiety and Depression (HADS) scores in patients with prosthetic eye using a single mean formula in 2017-2018 in Hospital Selayang and Hospital Universiti Sains Malaysia

2.2.3

To determine the potential predictors of NEIVFQ-25 & HADS(Anxiety), HADS(Depression) scores in patients with prosthetic eye using a multiple regression formula in 2017-2018 in Hospital Selayang and Hospital Universiti Sains Malaysia

(33)

20

CHAPTER 3

MANUSCRIPT

(34)

21

EVALUATION OF THE PSYCHOLOGICAL EFFECT AND VISION RELATED QUALITY OF LIFE IN

ENUCLEATED/EVISCERATED PATIENTS WITH PROSTHETIC EYES

Jeyarine Royan 1,2, Khairy Shamel Sonny Teo1, Asrenee Ab Razak3, Ong Poh Yan2

1Department of Ophthalmology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia

2Department of Ophthalmology, Hospital Selayang 68100, Selangor, Malaysia

3Department of Psychiatry, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia

Email addresses of all authors:

Jeyarine Royan jeyarineroyan@yahoo.com Khairy Shamel Sonny Teo khairy@usm.my

Asrenee Ab Razak asrenee@usm.my Ong Poh Yan dropy64@yahoo.com

(35)

22 Correspondence to:

Jeyarine Royan

Department of Ophthalmology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.

Email: jeyarineroyan@yahoo.com Tel: +6 09 767 6362

Fax: +6 09 765 3370

(36)

23 3.1 ABSTRACT

Background:

Patients with acquired anophthalmia post evisceration or enucleation surgeries are confronted with the loss of an eye and their vision.The aim of our study was to evaluate the levels of anxiety, depression and vision related quality of life in patients with prosthetic eyes post evisceration or enucleation and to determine the potential predictors associated with it.

Methods:

A cross sectional study was conducted between March 2017 and March 2018 involving patients with prosthetic eyes post evisceration or enucleation attending eye clinics of two tertiary hospitals in Malaysia; Hospital Selayang and Hospital Universiti Sains Malaysia.The patients were given two validated questionnaires: The National Eye Institute Visual Function Questionnaire – (NEI-VFQ) and the Hospital Anxiety and Depression (HADS) questionnaire.

The questionnaires were calculated and scored and descriptive statistical analysis was done using Statistical Package for the Social Science (SPSS Inc Version 22). & STATA version 14 software (StataCorp., 2015) for Multiple Linear Regression analysis.

Results:

A total of 54 patients participated in the study. The mean composite visual related quality of life was reduced with a score of 75.97.

(37)

24 The mean HADS (D) depression score was 1.94.The mean HADS(A) Anxiety score was 3.61.There were no significant associations between the demographic variables with vision related quality of life and depression levels.There were significant associations between the demographic variables and anxiety levels where p<0.05 for age, gender, duration of prosthesis wear and reason for prosthesis based on multi linear regression analysis.

Conclusion:

This study showed that the mean vision related quality of life scores in patients with prosthetic eyes post enucleation/evisceration was reduced however the mean anxiety and depression scores in these patients were within the normal range.

The predictors for anxiety levels in anopthalmic patients with prosthetic eyes was gender, age, duration of prosthesis wear, and cause for anophthalmia. There were no potential predictors for vision related quality of life or for depression.

Keywords:

Prosthetic eyes; quality of life; evisceration; enucleation

(38)

25 3.2 BACKGROUND

Anophthalmia is defined as the absence of the eye globe in the presence of ocular adnexa (lids, conjunctiva, lacrimal apparatus) which may be congenital or acquired.(1) Acquired anophthalmia may result either from evisceration or enucleations surgeries.

Evisceration is an ablative surgical technique in which the intraocular contents are removed via a corneal, paralimbal or scleral incision The contents that are removed include the retina, vitreous, lens and accessible uveal tissues, however the remaining sclera, Tenon’s capsule, conjunctiva, extra-ocular muscles, and the optic nerve and its surrounding meninges are still preserved.(2)

Enucleation is also an ablative surgical tecnique that involves the removal of the entire globe and its contents, while still preserving the surrounding periorbital and orbital structures such as the lids and ocular adnexae.

These surgeries are often completed by placing an implant into the orbital cavity to maintain appropriate orbital volume. This may help to prevent contracture of the orbital socket which will enable the use of an appropriate artificial (prosthetic) eye that will be both comfortable to the patient and not visibly apparent to the public.(3)

(39)

26 Destructive surgeries are performed in cases of blinding ocular trauma with irreparable ocular damage, intraocular malignancies, severe eye infections and painful non-functional eyes.

The term ‘eye amputated’ has been coined to describe patients who have lost their eye following a destructive surgery. (4, 5)

The decision to render a patient anophthalmic requires careful consideration and discussion between the physician, the patient and their family members as it is a traumatic experience with potentially profound psychological sequelae. After an evisceration or enucleation, a patient would have permanently lost the eye, some of their vision and a part of their face.(6) This can cause significant psychological sequelae, anxiety and depression.

Prosthetic or artificial eyes do not provide vision. Itreplaces an absent eye following destructive eye surgeries, such as evisceration or enucleation and has significant cosmetic value.(7) The process of losing an eye has psychological effect on a patient, hence a prosthesis should be provided as soon as possible for the comfort as well as psychological wellbeing of the patient.(8)

Prosthetic eyes are typically made of cryolite glass or medical grade plastic acrylic. They are available as readymade (stock) or custom-made prosthesis. Stock prosthesis is readily available in a few standard sizes, shapes, and colors and can be used in the interim or permanently.(9-12).Custom-made prosthesis is superior to stock prosthesis as there is better ocular motility, better fit and comfort and less likelihood of causing ulceration. There is also the obvious advantage of greater aesthetics as it is made to look like the fellow eye in terms of the pupil and iris size as well as the colour of the iris and sclera. (13-15)

(40)

27 Ideally, the psychological welfare of the patient should be evaluated prior to fitting and the nature of the ocular condition which led to the ablative procedure should be assessed, in the event of there being recurrence of the disease.(16)

Previous studies conducted in the United Kingdom, China, Korea & Nigeria have demonstrated that there is some level of anxiety and depression as well as a decreased vision related quality of life associated with having an ocular prosthesis.(7, 17-19)A major cause for this was due to the poorer vision related quality of life as well as due to concerns with facial appearance. Facial appearance was found to be an important factor on how they felt they are viewed by society at large and weather they felt discriminated.(18)

Poor vision related quality of life in anophthalmic patients is associated with monocular vision causing difficulties in performing daily activities and working while as many as 26%

of patients reporting to having pain, which is a part of the phantom eye syndrome.(17)

In the study by Mc Bain et al, positive psychosocial and demographic variables were related to living arrangements (not living alone) and having adequate support from family and friends.(18) A study done in China found that the variables which had positive indicators were age, where younger ages were found to be more anxious as well as those with lower levels of education.(17) On the other hand, in a study conducted in Korea, it was found that higher age, marriage and female gender was more associated with a greater negative impact on quality of life.(20)

It was found that 29.9% and 28.4% of anophthalmic patients obtained a range of scores from 8-21 in the HADS-A and HADS-D questionnaires respectively, which was comparable with the percentages seen in patients with other chronic diseases such as heart disease and cancer.(19)

(41)

28 According to the study by Mc Bain et al where the HADS was used as a screening tool, levels of anxiety and depression in patients with prosthetic eyes were within the normal to moderate range. However, there were a few patients with scores showing that they may be having a possible clinical diagnosis of anxiety and depression.(18)

In a study by Kondo et al., the NEI VFQ 25 as well as the Medical Outcomes Study Short Form 12, were used to assess vision and general health of anophthalmic patients as well as anxiety and depression.(21)

These studies were conducted in other countries; however, the vision related quality of life and levels of anxiety and depression amongst Malaysian patients with acquired anophthalmia and prosthetic eyes has not been assessed before.

The aim of this study is to determine if there is indeed levels of anxiety, depression and impact on the vision related quality of life in patients with prosthetic eyes in a Malaysian population. This study would also analyse and determine if the levels are correlated with the demographic, socioeconomic factors and ethnicity of the patients, which was not explored in previous studies.

The psychological and emotional aspects concerning anophthalmic patients with prosthetic eyes is often overlooked and poorly addressed by eye care providers. This study aims to establish if there is the need for psychiatric support or behavioral therapy in these patients, whereby the ophthalmologist would refer such patients to the appropriate channels.

The rationale of this study is to investigate if there is indeed reduced vision related quality of life and increased levels of anxiety and depression and the demographic variables related to them, in the context of Malaysian patients with prosthetic eyes.

(42)

29 3.3 METHODS

A cross-sectional study was conducted in two centers; Hospital Universiti Sains Malaysia, Kelantan and Hospital Selayang, Selangor, Malaysia from March 2017 to March 2018 The study followed the tenets of the declaration of Helsinki and was approved by two local ethical boards [USM/JEPeM/ l6080271] and [NMRR-16-2509-32485(IIR)]. The sample size was calculated using G Power 3.1.9.

A total of 54 patients were acquired for this study by convenience sampling in the ophthalmology /ocularist clinics. All unilateral anophthalmic patients with prosthetic eyes were considered for participation. Patients with a prosthetic eye following evisceration or enucleation surgeries were included in the study, provided they were aged 18 and above and could understand Malay or English sufficiently well to answer the questionnaires. Patients who had ocular disease in the fellow eye affecting their visual acuity or best corrected visual acuity worse than 6/12 were excluded from the study. Patients with facial disfigurements from concomitant trauma or severe mental illness which would preclude them giving consent to participate were also excluded.9 patients were excluded from the study.The demographic variables (age, race, gender, marital status, highest education level, monthly household income) and clinical variables (reason for enucleation/evisceration, duration of prosthesis wear) were obtained through direct questioning from patients and via perusal of medical records. The selection of variables was based on previous studies conducted overseas, with

(43)

30 the addition of the variable of race to reflect the multi-ethnic population in Malaysia. (17,19) Subjects who fulfilled the selection criteria were informed regarding the nature of study and written consent was obtained.

Vision-specific quality of life was measured using the National Eye Institute Visual Function Questionnaire (NEI VFQ-25), in both English and Malay. The NEI VFQ is an instrument to assess vision related quality of life. It comprises of a General Health subscale, and 11 vision- related subscales including: General Vision, Ocular Pain, Near Activities, Distance Activities, Social Functioning, Mental Health, Role Difficulties, Dependency, Driving, Color Vision, and Peripheral Vision. (22) The reliability and validity of the Malay version of the NEI VFQ in a Malay speaking population has been previously established.(23) A vision- specific composite score is calculated by averaging the vision-related subscale scores. Scores range from 0 to 100 with higher scores indicating better functioning.

Anxiety and Depression was measured using the Hospital Anxiety& Depression Scale (HADS) with English and Malay versions. The HADS consists of 14 categories encompassing two subscales: anxiety (HADS-A) with 7 categories and depression (HADS- D) with 7 categories. The score for each subscale can range from 0 to 21, where the higher the score, the greater the level of anxiety or depression. Scores of 0-7 are considered normal, 8-10 is moderate and more than 10 indicates a high possibility of clinical anxiety or depression. (18) The Malay version of HADS has been validated and recommended as an appropriate tool to measure depression and anxiety in Malaysia.(24, 25)

Subjects who enrolled in the study were informed about the nature of study and the procedure was explained to them in detail. Subjects willing to participate gave written consent and were given the Demographic data form and NEIVFQ-25 and HADS questionnaires which was

(44)

31 answered in the clinic, and any doubts or questions that arose was immediately answered in the clinic.Data was collected and organized. Individual subscores for all the vision related subscores of the NEIVFQ questionnaires were calculated and tabulated according to the described scoring algorithm published.(22) The HADS (A) and HADS (D) scores were also calculated and tabulated. Demographic and clinical data was tabulated and converted into numeric values, which was used during statistical analysis (coding of data).

The descriptive statistical analysis was carried out using Statistical Package for Social Sciences (SPSS) Version 22 & STATA version 14 software (StataCorp.,2015) for Multiple Linear Regression analysis.

3.4 RESULTS

3.4.1Demographic results

A total of 54 patients were recruited, 43 from Hospital Selayang and 11 from HUSM. There were 38 male patients (70.4%) and 16 female patients (29.6%). (Table 1) The ages of the subjects ranged from 19-76 years of age with a mean age of 45.11 years. There were 27 Malay patients (50%), 14 Chinese patients (25.9%) and 13 Indian patients (24.1%). There were 41 married patients (75.9%) and 13 single patients (24.1%).

There were 2 patients with a highest education level of primary school (3.7%), 35 patients with a secondary school education (64.8%) and 17 patients with a tertiary education (31.5%).

In the average monthly household income, there was 1 patient (1.9%) with an income for RM 1000-1999 ,22 patients (40.7%) with an income of RM 2000-2999,11 patients (20.4%) with an income of RM 3000-3999 and 20 patients (37%) with an income of more than RM 4000.

The commonest cause for enucleation or evisceration was trauma with 26 patients (48.1%), followed by infection with 12 patients (22.2%), painful blind eye with 9 patients (16.7%) and tumour with 7 patients (13%).

(45)

32 3.4.2 Mean NEI-VFQ Scores & Mean HADS (D) and HADS(A) scores

The mean Total/Composite score for the NEI-VFQ 25 was 75.97. (Table 2) For individual mean subgroup scores, the lowest mean subgroup score was for general vision (57.41) followed by Driving (67.77) and Role difficulties (68.83). The highest mean score was for colour vision (91.20) followed by social functions (82.18). The other mean subgroup scores were Mental health (72.49), Near activities (74.46), Peripheral vision (76.39), Ocular Pain (77.31), Dependency (77.77) and distant activities (78.75).

The mean HADS (D) Depression subscale was 1.94, with the range of scores from 0 to 8.

(Table 3) There were 53 patients (98.1%) with normal scores and 1 who scored more than 8 (1. 9%).The mean HADS (A) Anxiety subscale was 3.61 with the range of scores from 0 to 10. (Table 3) There were 48 patients (88.8%) with normal scores and 6 patients who scored more than 8 (11.2%).

3.4.3 Variables associated with vision related quality of life

Based on the simple linear regression formula and multiple linear regression formula, there were no associated demographic or clinical variables with the vision related quality of life, where the p level was > 0.05 for all the variables tested which was age, gender, race, marital status, monthly income, highest education level, clinical cause for surgery and duration of prosthesis wear. (Table 4)

3.4.4 Variables associated with Depression

Based on simple linear regression, there were 3 variables that is age, marital status and household income which were associated with the depression levels, as evidenced by p level

(46)

33 of <0.05. However, based on the multiple linear regression model, there were no significant predictors (p>0.05) when confounding effect was considered. (Table 5)

3.4.5 Variables associated with Anxiety

Simple linear regression analysis revealed age, marital status and monthly household income were associated with anxiety.

However, multiple linear regression demonstrated that there were four factors which were associated with anxiety when taking confounding effect into account. The age was a significant predictor of anxiety level [p-value: <0.001, b: -0.11, (95% CI: -0.17, -0.06)] when other factors were adjusted. (Table 6) On average, for every 1-year increase in a patients’

age, the anxiety score decreased by 0.11 unit.

Gender was significantly associated with anxiety level when other factors were adjusted for [p-value 0.042, b:1.49 (95% CI: 0.06, 2.92)]. On average the female patients had 1.49 points higher in anxiety scoring when compared to males.

The cause of treatment was a significant associated factor of anxiety. The infection group had 1.76 score lower when compared to trauma group when other factors were adjusted [p-value:

0.022, b: -1.76 (95%CI: -3.26, -0.26)]. On the other hand, the painful eye group had 2.13 score lower compared to trauma group [p-value: 0.042, b: -2.13 (95% CI: -4.18, -0.09)].

However, there was no significant difference between tumour group and trauma group.

Duration of prosthesis was a significant predictor of anxiety level. Those who had duration of prosthesis between 1 to 5 years have 1.57 points lower of anxiety level compared to those less than 1 year [p-value: 0.043, b: -1.57 (95%CI: -3.09, -0.05)]. Those who have prosthesis

(47)

34 more than 5 year had 1.93 points lower compared to those less than 1 year [p-value: 0.028, b:

-1.93 (95%CI: -3.64, -0.22)]. The multiple linear regression model explained 73% of variation in anxiety level. (R2 = 0.73).

Other predictors such as race, marital status, highest education level and income were not associated with anxiety levels.

3.5 DISCUSSION

Evisceration and enucleation are ablative surgeries reserved for ocular conditions that are not amenable to treatment as well as conditions causing morbidity and potential mortality to a patient. Predisposing conditions are severe ocular trauma, ocular malignancy, severe ocular infections and painful non-functional eyes due to various pathologies. The outcome of surgery is acquired anophthalmia followed by ocular prosthesis to provide cosmesis.

The aim of this study was to determine if patients with prosthetic eyes have reduced vision related quality of life and levels of anxiety and depression.

In this study, the NEI-VFQ 25 and the HADS were the survey instruments used to investigate the vision related quality of life and levels of anxiety and depression in anophthalmic patients post evisceration/enucleation with prosthetic eyes.

The mean NEI-VFQ score was indeed reduced with a composite score of 75.97. This composite score is comparable to the mean composite scores in other studies by Ye et al, Kondo et al and Hirneiss at al which had scores of 70.3,80 and 80 respectively.(17, 21, 26).

(48)

35 The similar composite scores which were obtained by all studies when evaluating the vision related quality of life in monocular patients with a prosthetic eye would largely be due to their current state of monocular vision. The degree of visual related quality of life in patients with monocular vision differs from one individual to the next and may depend on the time at which the patient had been rendered monocular.

As stated by Linberg et al in their study on loss of vision in one eye, the recovery following the event of unilateral visual loss requires an adjustment to monocular vision. The same study found that such patients could resume their daily activities after a short period of adjustment.(27) This could perhaps account for the mean composite scores in vision related quality of life in our study.

The mean HADS scores for both anxiety and depression was in the normal range. The percentage of patients who scored more than 8 was 1.9% for HADS-A and 11.2% for HADS- D. In the study by Mc Bain et al, up to 18% of patients had mild and moderate scores for both HADS-A and HADS-D despite the mean scores being within normal range.(18) In the study by Ahn et al in Korea, the mean scores were also within normal range, however there was a rate of 29.9 % and 28.4% of patients who scored 8 or more on the HADS-A and HADS-D scores.(19) Ye at al found that the prevalence rates of anxiety and depression in their cohort was 11.8% and13.8% respectively. (17)

Mc Bain et al suggest that the psychological effect found in anopthalmic patients with prosthesis does not correlate with the clinical and demographic variables such as duration of prosthesis, age or gender; but rather more about the patients concerns with their appearance, social acceptance and pessimistic views on their condition.(18) Similarly, the study by Ye et

(49)

36 al found that greater anxiety and depression was associated with poor vision related quality of life and concerns about appearance. (17)

In this study, unlike the ones mentioned above, there were no specific tools used to measure how the patients felt about their appearance and if they had difficulty with social interactions which could affect their scores. Therefore, this important factor related to anxiety and depression was not assessed and may have been useful in explaining the reduced levels of anxiety and depression in this study. In the subscales of the NEI VFQ that examined social and psychological features, the mean scores for social functioning, mental health and ocular pain was 82.18, 72.49 and 77.31 respectively. These scores indicate that the patients fared quite well in the subscales related to psychological states which might also explain the reduced levels of anxiety and depression.

There were significant predictors for anxiety which wasage, gender, clinical cause for surgery and duration of prosthesis wear. The similar predictor with this study and the study by Ye et al was age, where they also found that younger anophthalmic patients had greater levels of anxiety. Jorm, (28) concluded that there is some evidence that ageing is associated with an intrinsic reduction in susceptibility to anxiety and depression. This could possibly account for the similar results in both studies. There were no significant predictors for depression in this study.Ye et al (17) found that lower levels of education were a predictor for depression, and that clinical variables alone failed to explain much of the variances in anxiety and depression.

The cause for treatment was a significant variable with trauma and infection being more predictive of anxiety. Patients with ocular trauma undergo significant psychological pressures and may have anxiety, depression and fear.(29) Duration of prosthesis was also a predictor

(50)

37 for anxiety, where the group with prosthesis for longer periods of time had lower anxiety scores compared to those in the less than 1 year group. This data suggests that a longer duration of prosthesis wear has lower anxiety levels, likely due to the patient having adjusted to wearing the prosthesis, as well as having had more time to cope with acquired anophthalmia.

There were no significant predictors for vision related quality of life in this study. Previous studies conducted did not investigate if there were predictors for vision related quality of life in patients with prosthetic eyes.(17, 18, 21) As such, there are no comparable studies to establish if there are any predictors solely for vision related quality of life in anophthalmic patients. The study by Ahn et al investigated the predictors associated with general quality of life (not vision) and found that the higher age and female gender was associated with a lower quality of life.(19)

LIMITATIONS AND RECOMMENDATIONS

There were some limitations of this study. As with any form of self-reporting measures, there may be some element of response bias when the respondents fill up the questionnaires.

As mentioned earlier, our study did not assess the respondents’ response to facial appearance. Therefore, our study did not address the appearance associated concerns in these patients, which could be a factor in their psychological response to having a prosthetic eye.

Another limitation was the cross-sectional nature of the study which may limit the attributions about the direction of causality between variables. As Mc Bain et al (18) pointed

(51)

38 out, the cross-sectional nature of their investigation precluded how patients may change over time and adjust to their prosthesis.

Perhaps a suitable way to encounter this in the future would be to assess these patients with the questionnaires at various points of time, such as immediately after they start using a prosthesis, at 3 monthly intervals for the first year and thereafter annually. This would allow the ophthalmologist to examine the patients psychological state at various times and detect any subtle changes that may require a referral to either a counsellor or psychiatrist. The other limitation of a cross sectional study is the difficulty in establishing correlation between variables.

3.6 CONCLUSION

This study showed that anopthalmic patients with prosthetic eyes have decreased mean vision related quality of life however the mean anxiety and depression scores in these patients were within the normal range

This study showed that the predictors of anxiety levels in anophthalmic patients with prosthetic eyes were age, gender, shorter duration of prosthesis wear and the cause of anophthalmia.

This study showed that there were no potential predictors for vision related quality of life and depression levels in anophthalmic patients with prosthetic eyes.

3.7 DECLARATIONS

(52)

39 3.7.1 Ethics approval and consent to participate

The study followed the tenets of the declaration of Helsinki and were approved by the local ethical boards USM/JEPeM/ l6080271] and [NMRR-16-2509-32485(IIR)]. Written informed consent to participate was obtained for each patient prior to the study.

3.7.2 Consent for publication

All authors gave consent to publish the manuscript.

3.7.3 Availability of data and materials

All data generated or analyzed during this study are included in this published article. More details are available from the corresponding author on reasonable request.

3.7.4 Competing interests

The authors declare that they have no competing interests.

3.7.5 Funding

This work is supported by the researchers

3.7.6 Authors’ contributions

JR, KS and, AR contributed to the design of the study; JR involved in data collection; JR and KS contributed to statistical analysis; JR and KS prepared the manuscript; JR drafted the manuscript; and KS crucially revised the manuscript. All authors have read and approved the final manuscript.

Rujukan

DOKUMEN BERKAITAN

Objektif utama kajian ini adalah untuk mengkaji impak tingkahlaku kepimpinan dan komitmen organisasi dalam kalangan pekerja terhadap kualiti perkhidmatan dalam

Kajian ini penting untuk menentukan penerimaan pelajar Fakulti Kejuruteraan dan Alam Bina (FKAB) terhadap aktiviti pemeliharaan alam sekitar yang dijalankan secara sukarela

Objektif kajian ini adalah untuk membincangkan isu bahasa dalam kalangan peserta warga Jepun yang menyertai program Malaysia My Second Home (MM2H).. Metodologi kajian yang

Having spent nearly four decades in undertaking research and writing on the societies and cultures of Borneo, and indeed more widely in Southeast Asia, I thought that, on the

Lebih penting lagi, kajian terkini telah mendedahkan bahawa kesan kepuasan kerja bersifat ekstrinsik dan intrinsik ke atas keinginan untuk berhenti secara sukarela adalah

Anda adalah dipelawa untuk menyertai satu kajian penyelidikan secara sukarela tentang hubungan antara tahap aktiviti fizikal yang dilaporkan sendiri dan

Secara khususnya, kajian ini meninjau (i) pengaruh kategori sekolah terhadap faktor dalaman sekolah, kualiti kehidupan kerja guru, dan komitmen guru terhadap organisasi,

Anda dipelawa untuk menyertai satu kajian mengenai kes-kes jantung yang dikendalikan serta dirawat di zon merah ( zon kritikal) di Jabatan Kecemasan Hospital Universiti Sains