RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,

KARNATAKA.

SYNOPSIS OF

DISSERTATION

" CLINICAL STUDY TO EVALUATE THE EFFICACY OF SURGICAL TRABECULECTOMY IN CONTROLLING

INTRAOCULAR PRESSURE IN PRIMARY ADULT ONSET OPEN ANGLE GLAUCOMA IN RURAL POPULATION "

Submitted by

Dr. AMARTYAJIT MUKHERJEE,M.B.B.S.

POST GRADUATE STUDENT IN OPHTHALMOLOGY (M.S.)

Under the guidance of

Prof. Dr. PADMINI. H.R., M.B.B.S., M.S., D.O.M.S.

PROFESSOR & HEAD,DEPARTMENT OF OPHTHALMOLOGY

A.I.M.S., B.G.NAGARA-571448.

DEPARTMENT OF OPHTHALMOLOGYADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,

B.G.NAGARA-571448

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 NAME OF THE CANDIDATEAND ADDRESS(in block letters)

Dr. AMARTYAJIT MUKHERJEE# 62, KALPATHARU BHAVANA,P.G. HOSTEL, A.I.M.S.,B.G.NAGARA. NAGAMANGALA TALUK, MANDYA DISTRICT-571448KARNATAKA.

2. NAME OF THE INSTITUTION ADICHUNCHANAGIRI INSTITUTE OFMEDICAL SCIENCES, B.G.NAGARA.

3. COURSE OF STUDY AND SUBJECT M.S. IN OPHTHALMOLOGY

4. DATE OF ADMISSION TO COURSE 25/04/2011

5. TITLE OF THE TOPIC"CLINICAL STUDY TO EVALUATE THE

EFFICACY OF SURGICAL TRABECULECTOMY IN CONTROLLING INTRAOCULAR PRESSURE IN PRIMARY

ADULT ONSET OPEN ANGLE GLAUCOMA IN RURAL POPULATION"

6.BRIEF RESUME OF INTENDED WORK

6.1 NEED FOR THE STUDY

6.2 REVIEW OF LITERATURE

6.3 OBJECTIVES OF THE STUDY

APPENDIX-I

APPENDIX-IA

APPENDIX-IB

APPENDIX-IC

7 MATERIALS AND METHODS

7.1 SOURCE OF DATA

7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE IF ANY)

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.

7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3

APPENDIX-II

APPENDIX-IIA

APPENDIX-IIB

YESAPPENDIX-IIC

YESAPPENDIX-IID

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8. LIST OF REFERENCES APPENDIX – III

9. SIGNATURE OF THE CANDIDATE

10. REMARKS OF THE GUIDEPrimary open angle glaucoma is a common ocular disease in the outpatients which requires both medical and surgical management. Many times the patients have to be subjected to surgical treatment, mainly trabeculectomy. Hence the need to evaluate the visual outcome among those cases who undergo trabeculectomy. Hence I recommend this study in a rural place like this.

11 NAME AND DESIGNATION (in Block Letters)

11.1 GUIDE Dr. PADMINI. H.R. MBBS, MS, DOMS

PROFESSOR AND HEADDEPARTMENT OF OPHTHALMOLOGY,AIMS, B.G. NAGARA-571448

11.2 SIGNATURE OF THE GUIDE

11.3 CO-GUIDE (IF ANY) -

11.4 SIGNATURE -

11.5 HEAD OF DEPARTMENT Dr. PADMINI. H.R. MBBS, MS, DOMS

PROFESSOR AND HEADDEPARTMENT OF OPHTHALMOLOGY,AIMS, B.G. NAGARA-571448

11.6 SIGNATURE

2

12 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL

The facilities required for the investigation will be made available by the college

Dr. M.G SHIVARAMU MBBS, MD

PRINCIPAL, AIMS, B.G. NAGARA.

12.2 SIGNATURE

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APPENDIX-I

6. BRIEF RESUME OF THE INTENDED WORK:

APPENDIX – I A

6.1 NEED FOR THE STUDY:

Glaucoma is the leading cause of irreversible blindness all over the world and

constitutes one of the greatest problems in ophthalmology worldwide. Glaucoma has been

nicknamed the " silent thief of sight " because the loss of vision normally occurs gradually over

a long period of time, and is often only recognized when the disease is quite advanced. Once

lost, this damaged visual field cannot be recovered. Worldwide, it is the second leading cause

of blindness after cataract 1.

India is a vast country with over a billion people. Based on the results of the

population-based studies conducted in different parts of India till now, 2-6 George et al. 7

reported the burden of glaucoma in India to be 11.2 million. Of these, primary open-angle

glaucoma (POAG) was estimated to be 6.48 million and primary angle-closure glaucoma

(PACG) was 2.54 million.8

Intraocular pressure is considered to be the main risk factor for the development of

glaucoma and its progression. Trabeculectomy is one such surgical procedure which helps in

decreasing and maintaining the intra ocular pressure, thus helping in arresting the progression

of the disease. Since the late 1960’s, trabeculectomy has been the operation of choice for

improving aqueous outflow in glaucomatous eyes (Cairns 1968, Watson & Grierson 1981) and

trabeculectomy is still regarded as the gold standard to which the newer operations are

compared.

4

Close to 70% of the country's population reside in villages. There are obvious

differences in the availability and access to health care between the urban and rural parts of the

country. While the people in the cities have access to the latest technologies, there is no care

available in the rural areas. The Eye Health Pyramid of LV Prasad Eye Institute with its village

vision complex system is a potential model to address this issue of access to affordable

comprehensive eye care in rural India.9

This prospective study is therefore undertaken to outline the efficacy (i.e. control of

IOP) of Trabeculectomy in POAG (adult onset) in rural population.

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APPENDIX –I B

6.2 REVIEW OF LITERATURE

In Hippocratic era, a disorder leading to blindness in the advancing years characterized

by a greenish or bluish grey pupil and if this occurred quickly and completely, there would be

no hope for visual recovery, was well known as "Glaucosis". The word ‘glaucoma’ was

probably derived from this.

1622: Richard Bannister suggested the association between glaucoma and elevated

intraocular pressure (IOP). Till 19th century, when this link had become generally

accepted were various surgical attempts made to treat glaucoma by reducing ocular

tension.

1968 - Cairns reported good success in 17 eyes using microsurgical techniques to

perform a "Trabeculectomy" under a scleral flap which was hinged either posteriorly in

the sclera or anteriorly at the limbus.

But gradually, trabeculectomy became the procedure of choice because although the

success rate in lowering the intraocular pressure was not higher, incidence of

complications was relatively low.

Trabeculectomy thus has been widely accepted as the surgical procedure of choice for

glaucoma and still newer modifications of this technique are being developed for the better

management of glaucoma.

Glaucoma is a heterogeneous group of disorders in which intraocular pressure (IOP) is

too high for normal functioning of optic nerve. Basically it is so variable that it is impossible to

know the IOP level tolerance limit of individual eye. So various terms have come into

existence to explain the different situations like too high IOP without optic nerve damage and

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too low IOP with glaucomatous optic nerve damage. So the terms like Normal tension

glaucoma and Low tension glaucoma have come into existence.10

Classification of Glaucoma

Our classification is based on the latest terminology adopted by European Glaucoma

Society11. According to this classification:

1. PRIMARY OPEN ANGLE GLAUCOMAS: It is further divided into

a. Primary juvenile glaucoma

b. Primary juvenile glaucoma suspect

c. Primary open angle glaucoma (POAG)

d. Primary open angle glaucoma suspect (POAG-SUSPECT)

e. Normal pressure glaucoma (NPG)

f. Normal pressure glaucoma suspect (NPG-SUSPECT)

g. Ocular hypertension

2. SECONDARY OPEN ANGLE GLAUCOMAS.

3. PRIMARY ANGLE CLOSURE GLAUCOMAS.

4. SECONDARY ANGLE CLOSURE GLAUCOMAS.

MANAGEMENT

It is generally done as medical management and surgical interventions.

MEDICAL MANAGEMENT

Major drug classes for medical treatment of POAG include Alpha agonists, beta-

blockers, carbonic anhydrase inhibitors, miotic agents and prostaglandin analogues.

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SURGICAL MANAGEMENT

With the recent advancement in the field of POAG, various surgical options are

available now a day. However to name a few are:

Argon laser trabeculoplasty

Selective laser trabeculoplasty

Trabeculectomy

Drainage implant(i.e. seton/tube/shunt) surgery

Ciliary body ablation

Deep sclerectomy/viscocanalostomy/with or without collagen implant

360-degree suture canaloplasty (iscience)

In a recent study performed for long term evaluation and comparison of trabeculectomy

in primary open angle glaucoma (POAG) and chronic primary angle closure glaucoma

(CPACG) in Asian population ,sixty four eyes of 64 patients with a minimum of 5 years

follow up were studied, and it was concluded that trabeculectomy without antimetabolite use

appeared to be efficacious in lowering IOP and in visual field preservation over a period of 10

years both in POAG and CPACG.12

In another study on long term IOP control of trabeculectomy and triple procedure in

POAG and CPACG,1542 eyes of 900 patients of POAG or CPACG were included in the

study. It was then concluded that trabeculectomy and triple procedure was effective in reducing

IOP for up to 15 years after surgery.13

Trabeculectomy is thus one such surgical procedure which helps in decreasing and

maintaining the intra ocular pressure, thus helping in arresting the progression of the disease.

8

APPENDIX –IC

6.3 OBJECTIVES OF THE STUDY

To evaluate the efficacy of surgical trabeculectomy in reducing IOP in patients

suffering from Primary Adult Onset Open Angle Glaucoma in rural population.

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APPENDIX-II

7.0 MATERIALS AND METHODS

APPENDIX-II A

7.1 SOURCE OF DATA

The material for the present study of 18 months duration is proposed to be collected

from the patients presenting themselves directly to Department of Ophthalmology

(Adichunchanagiri Institute of Medical Sciences, B.G. Nagara) with primary adult onset open

angle glaucoma and undergoing trabeculectomy will be taken up for the study.

A prospective cohort study of a sample size of a minimum of 40 patients fulfilling the

mentioned inclusion criteria will be a part of this study.

APPENDIX-II B

7.2 METHOD OF COLLECTION OF DATA

All patients on routine screening having adult onset primary open angle glaucoma will

be selected for this study.

INCLUSION CRITERIA:

1. All patients of adult onset primary open angle glaucoma failing to respond to medical

management.

2. Poor compliance of the patients because of poor education as well as distance factor

from assessing tertiary health care in a rural place.

3. Cost factor of the drugs especially when combination therapy is prescribed.

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EXCLUSION CRITERIA:

1. Patients diagnosed with secondary glaucoma, congenital glaucoma, angle closure glaucoma.

2. Patients who have undergone trabeculectomy.

3. Patients who have undergone argon laser trabeculoplasty.

4. Primary juvenile glaucoma and juvenile glaucoma suspect.

APPENDIX-II C

7.3 Does the study require any investigation or intervention to be conducted on the

patients or animals, if so please describe briefly

YES

It requires the following investigations to be conducted on patients included in the study.

INVESTIGATION

Detailed history needs to be recorded in all the cases prior to investigations.

Ophthalmological Examination

Patients entering the record will be subjected to full ophthalmic assessment including:

LOCAL EXAMINATION:

Detailed local examination of the eyes to be carried out starting with

Determination of visual acuity by Snellen’s chart and near vision chart.

External ocular examination.

Detailed torch light examination including pupillary reflex and anterior chamber

depth

Detailed Slit lamp examination.

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GONIOSCOPY is to be done using Goldman three mirror lens.

IOP MEASUREMENT using Goldman’s applanation tonometer.

VISUAL FIELD central 30° with Automated perimeter.

FUNDUS EXAMINATION using Direct Ophthalmoscope and 90 D Lens.

FUNDUS PHOTOGRAPHY using Zeiss fundus camera.

Laboratory investigations

Hemoglobin.

B.T., C.T

HIV, HbsAg

Urine examination for albumin and sugar

Intervention

All patients on oral anti-glaucoma drugs selected for the surgery will be advised to stop

miotics and beta-blockers 48 hours before the surgery. All cases would be put on oral

Acetazolamide 250mg TID on the day prior to surgery and to receive 1.5gm / kg body

weight of 20% Mannitol intravenous 1-2 hrs. prior to surgery.

Surgical trabeculectomy is to be performed in the operation theatre of

ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES with prior

hospitalization and requires local anesthesia to be advocated by the peri-bulbar

technique.

Conjunctival cul-de-sac is to be irrigated with 1:10 Povidone iodine solution. All the

patients are proposed to undergo fornix based trabeculectomy in the superior quadrant

by modified Cairn's technique. A wire speculum is to be employed for exposure and a

superior rectus Bridle stitch about 10-12 mm away from the limbus will be an aid to

fixation of the globe. Fornix based conjunctival flap to be raised. Tenonectomy has to

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be done; ball point thermal cautery can be used minimally to cauterize the bleeding

vessels. A rectangular (4 x 5mm) or triangular flap of (3 x 3mm or 4 x 4 mm), 2/3 to

1/2 scleral thickness has to be raised. An inner block of trabecular tissue 1x2 mm or

1x3 mm size needs to be excised. A broad based peripheral iridectomy has to be

performed. The anterior chamber will be irrigated with Ringer lactate and viscoelastic

to be removed. The scleral flap is reapposed with 3 interrupted 10 -0 nylon sutures and

2 buried interrupted 10-0 nylon sutures in the triangular and rectangular flaps

respectively. Conjunctival flap is proposed to be sutured with interrupted sutures. The

conjunctiva needs careful observation for areas of button holing. 2 mg dexamethasone

and 20 mg gentamycin is injected subconjunctivally in the inferior fornix, at the end of

the procedure. Pads and bandages are applied for 24 hrs.

Following trabeculectomy, all patients are planned to be kept for hospitalization and

put on oral antibiotics analgesic and anti-inflammatory drugs for 3-5 days post-

operatively. Topically (0.1%), Dexamethasone (0.1%) or Betamethasone and

ciprofloxacin eye drops to be used 4-6 hourly along with cycloplegics (Homatropine), 6

hourly which has to be tapered over 4-6 weeks.

Bandage has to be removed on first post-operative day and the patient needs to be

followed up thoroughly till the time of discharge (usually 4th post op day) and then has

to be regularly followed up at 2nd, 4th and 6th week postoperatively including thorough

examination under the slit lamp bio microscopy, visual acuity using Snellen’s chart,

IOP recording with Goldman’s applanation tonometer, direct and indirect

ophthalmoscopy.

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APPENDIX-IID

PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION A

a Title of the study

"CLINICAL STUDY TO EVALUATE THE EFFICACY OF SURGICAL

TRABECULECTOMY IN CONTROLLING INTRAOCULAR PRESSURE IN PRIMARY

ADULT ONSET OPEN ANGLE GLAUCOMA IN RURAL POPULATION"

b Principle investigator(Name and Designation)

Dr. AMARTYAJIT MUKHERJEEP.G IN OPHTHALMOLOGY ,ADICHUNCHUNAGIRI INSTITUTE OFMEDICAL SCIENCES.B.G NAGARA,MANDYA DISTRICT -571448.

c Co-investigator(Name and Designation)

Dr. PADMINI. H.R. MBBS, MS, DOMS

PROFESSOR AND HEADDEPARTMENT OF OPHTHALMOLOGY,AIMS, B.G. NAGARA-571448

d Name of the CollaboratingDepartment/Institutions

DEPARTMENT OF PATHOLOGY, MICROBIOLOGY AND MEDICAL

EDUCATION

eWhether permission has been obtained from the heads of the collaborating departments & Institution

YES

Section – B Summary of the Project APPENDIX I

Section – C Objectives of the study APPENDIX IC

Section – DMethodology APPENDIX IIB

A Where the proposed study will be undertaken

ADICHUNCHANAGIRI HOSPITAL AND RESEARCH CENTRE, B.G. NAGARA

B Duration of the Project 18 MONTHS

C Nature of the subjects:

Does the study involve adult patients?

Does the study involve Children?

Does the study involve normal volunteers?

Does the study involve Psychiatric patients?

Does the study involve pregnant women?

YES

NO

NO

NO

NO

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D If the study involves health volunteers

I. Will they be institute students?

II. Will they be institute employees?

III. Will they be paid?

IV. If they are to be paid, how much per

session?

NO

NO

NO

NA

E Is the study a part of multi central trial? NO

F If yes, who is the coordinator?(Name and Designation)

Has the trial been approved by the ethics Committee of the other centers?

If the study involves the use of drugs please indicate whether. I. The drug is marketed in India for the indication in which it will be used in the study.

II. The drug is marketed in India but not for the indication in which it will be used in the study

III. The drug is only used for experimental use in humans.

IV. Clearance of the drugs controller of India has been obtained for:

Use of the drug in healthy volunteers Use of the drug in-patients for a new

indication. Phase one and two clinical trials Experimental use in-patients and healthy

volunteers.

NA

NA

YES

NO

YES

NO

NO

NA

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G How do you propose to obtain the drug to be

used in the study?

- Gift from a drug company

- Hospital supplies

- Patients will be asked to purchase

- Other sources (Explain)

NO

YES

NO

NO

H Funding (If any) for the project please state

- None

- Amount

- Source

- To whom payable

NA

IDoes any agency have a vested interest in the

outcome of the Project? NO

JWill data relating to subjects /controls be stored

in a computer? YES

K

Will the data analysis be done by

- The researcher?

- The funding agent

YES

NO

L Will technical / nursing help be required form

the staff of hospital.

If yes, will it interfere with their duties?

Will you recruit other staff for the duration of

the study?

If Yes give details of

I. Designation

II. Qualification

III. Number

IV. Duration of Employment

YES

NO

NO

NA

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M Will informed consent be taken? If yes

Will it be written informed consent:

Will it be oral consent?

Will it be taken from the subject themselves?

Will it be from the legal guardian? If no, give

reason:

YES

NO

YES

YES

N Describe design, Methodology and techniques APPENDIX II

Ethical clearance has been accorded.

Chairman,P.G Training Cum-Research Institute,

A.I.M.S., B.G.Nagara.Date:

PS: NA – Not Applicable

17

APPENDIX-III

8. LIST OF REFERENCES

1. Resnikoff S, et al. Global data on visual impairment in the year 2002. Bull World Health

Organ. 2004 Nov; 82(11):844-51.

2. Jacob A, Thomas R, Koshi SP, Braganza A, Muliyil J. Prevalence of primary glaucoma in

an urban south Indian population. Indian J Ophthalmol 1998; 46: 81-86.

3. Ramakrishnan R, Nirmalan PK, Krishnadas R, et al. Glaucoma in a rural population of

southern India: the Aravind comprehensive eye survey. Ophthalmology 2003; 110: 1484-

1490.

4. Vijaya L, George R, Baskaran M, et al. Prevalence of primary open-angle glaucoma in an

urban south Indian population and comparison with a rural population. The Chennai

Glaucoma Study. Ophthalmology 2008; 115: 648-654, e641.

5. Vijaya L, George R, Arvind H, et al. Prevalence of primary angle-closure disease in an

urban south Indian population and comparison with a rural population. The Chennai

Glaucoma Study. Ophthalmology 2008; 115: 655-660, e651.

6. Garudadri C, Senthil S, Khanna RC, Sannapaneni K, Rao HB. Prevalence and risk factors

for primary glaucomas in adult urban and rural populations in the Andhra Pradesh Eye

Disease Study. Ophthalmology 2010; 117: 1352-1359.

7. George R, Ve RS, Vijaya L. Glaucoma in India: estimated burden of disease. J Glaucoma

2010; 19: 391-397.

8. Rao HL, Kumar AU, Babu JG, Senthil S, Garudadri CS. Relationship between Severity of

Visual Field Loss at Presentation and Rate of Visual Field Progression in Glaucoma.

Ophthalmology 2010 (e-pub. ahaid of print).

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9. Thomas R, Naveen S, Nirmalan PK, Parikh R. Detection of ocular disease by a vision-

centre technician and the role of frequency-doubling technology perimetry in this setting.

Br J Ophthalmol 2010; 94: 214-218.

10. Shields MB. Textbook of Glaucoma. 4th ed. Baltimore: Williams and Wilkins, 1997: 1-2

11. EGS (Europe). Terminology and guidelines for glaucoma. Italy: EGS; 1998.

12. Sihota R, Gupta V, Agarwal HC. Long-term evaluation of trabeculectomy in primary open

angle glaucoma and chronic primary angle closure glaucoma in an Asian population. Clin

Experiment Ophthalmol. 2004 Feb; 32(1):23-8.

13. Samin Hong, Kyoungsoo Park, Seung Joo Ha, Ho Yeop Yeom,Gong Je Seong, Young Jae

Hong. Long-term intraocular pressure control of trabeculectomy and triple procedure in

primary open angle glaucoma and chronic primary angle closure glaucoma.International

Journal of Ophthalmology. (2007); 221(6): 395-401.

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