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COMPARATIVE EVALUATION OF PHACOTRABECULECTOMY

VERSUS

PHACOTRABECULECTOMY WITH AUTOLOGOUS ANTERIOR

LENS CAPSULE APPLICATION IN THE SUCCESS OF

TRABECULECTOMY SURGERY

Protocol of the thesis to be submitted to the University of Delhi

towards the Partial Fulfillment of the Requirement for the Degree

of Master of Surgery (Ophthalmology)

By

DR. SABITABH KUMAR

(Batch: 2013 to 2016)

Department of OphthalmologyUniversity College of Medical Sciences & GTB Hospital

Delhi 110095


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COMPARATIVE EVALUATION OF PHACOTRABECULECTOMY

VERSUS

PHACOTRABECULECTOMY WITH AUTOLOGOUS ANTERIOR

LENS CAPSULE APPLICATION IN THE SUCCESS OF

TRABECULECTOMY SURGERY

Protocol of the thesis to be submitted to the University of Delhitowards the Partial Fulfillment of the Requirement for the

Degree of Master of Surgery (Ophthalmology)

(Batch: 2013 to 2016)

Candidate : Dr. Sabitabh Kumar _________________Signature

Supervisor : Dr. G.K. Das _________________Professor, SignatureDepartment of Ophthalmology,UCMS & GTB Hospital, Delhi

Co-supervisor : Dr. P.K. Sahu _________________

Professor, SignatureDepartment of Ophthalmology,UCMS & GTB Hospital, Delhi

: Dr. Vinod Kumar _________________Assistant Professor, SignatureDepartment of Ophthalmology,UCMS & GTB Hospital, Delhi

: Dr. Bhuvan Chanana _________________Assistant Professor, Signature

Department of Ophthalmology,UCMS & GTB Hospital, Delhi

Place of work:Department of Ophthalmology

University College of Medical Sciences and GTB Hospital,Delhi-110095


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SUMMARY OF PROTOCOL

Study title: Comparative evaluation of phacotrabeculectomy versus

phacotrabeculectomy with autologous anterior lens capsule (ALC) application in

the success of trabeculectomy surgery.

Purpose: To determine whether the autotransplantation of human anterior lens

capsule (ALC) in the trabeculectomy site can aid better filteration.

Aims and Objective:

1. To evaluate and compare type of bleb formation with and without ALC implant

in cataract with glaucoma after phacotrabeculectomy.

2. To evaluate/compare IOP reduction with and without ALC auto

transplantation.

3. To compare status of bleb and IOP reduction at 3 months follow-up in both

the groups.

4. To evaluate the ocular complications with and without ALC implant in cataract

with glaucoma.

Setting: Inpatient, Department of Ophthalmology, University College of Medical

Sciences and Guru Teg Bahadur hospital, Delhi-110095.

Study design: Prospective interventional case control study.Time frame: November 2013 to March 2015

Population/ Participants: 62 patients, 31 each in two groups (patients with

phacotrabeculetomy and patients with ALC auto transplantation in

phacotrabeculectomy) of coexisting cataract and glaucoma will be enrolled in this

study. The patient with history of uveitis, previous ocular surgery, hard cataract

(Grade IV) or systemic diseases such as diabetes mellitus will be excluded from

the study.

Sample size: 62 patients (each patient having coexisting cataract and

glaucoma).

Methods: After taking informed consent, all 62 patients would undergo pre-

operative examination for cataract and glaucoma (Refraction, applanation

tonometry, slit lamp examination, fundus examination using direct


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ophthalmoscopy). Combined phacoemulsification, posterior chamber intraocular

lens implantation in the bag and trabeculectomy will be performed in both cases

and controls. The anterior lens capsule autotransplantation will be performed in

31 eyes (case).

Follow-up period will be 3 months. The appearance of different type of bleb 31

(Table 1) type I, type II, type III and type IV will be compared between the two

groups. The IOP change before surgery and after surgery till 3 months follow-up

will be compared. Any other ocular complication will be noted.

Outcome measures: (1) Comparison of different type of bleb till 3 months

follow-up in both the groups.

(2) Comparison of IOP before and after surgery till 3 months follow-up in both the

groups.

Data management Statistical analysis: Chi-square test to compare bleb

formation between two groups. Repeated measures ANOVA for inter and intra

comparison of IOP.

Reason for the sample size: A sample size 31 per group with 80%power and

5% level of significance to detect a difference between phacotrabeculectomy and

phacotrabeculectomy with anterior lens capsule proportion of 0.19(0.99 in

phacotrabeculectomy and 0.80 in phacotrabeculectomy with anterior lens

capsule) is adequate.

Power of study: 80%

Level of significance: 5%


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INTRODUCTION

Glaucoma is a potentially blinding disease that affects all age groups and all

populations. The aetiology of glaucomatous damage is not very clear yet.Controlling the intraocular pressure (IOP) at an early stage in glaucoma has been

shown to slow down or stop progression of the disease.1,2

Presently, lowering of

IOP is the main goal of glaucoma therapy. Trabeculectomy, introduced by

Cairns3

in 1968, has become the gold standard filtering procedure for many eyes

with glaucoma. However, in some cases, it cannot achieve a good filtering effect

because of post-operative fibrosis at the filtering site, which reduce or abolish

aqueous flow from the eye into the subconjunctival space. In order to reduce the

fibrosis response, antimetabolites such as mitomycin-C (MMC) and 5-fluorouracil

(5-FU) have been used in trabeculectomy. However, their antimetabolism effect

is often compromised by a number of serious ocular complications, such as bleb

leakage, prolonged hypotony, epitheliopathy, blebitis, endophthalmitis, etc.4-8

Biomaterials have been studied to enhance the success of filtering procedures,

such as horse hair, silk threads, acrylic plates, gelatin, amniotic membrane, etc32

They are too expensive for most patients in the developing countries to use, and

these materials are not autogenous. Anterior lens capsule (ALC), the thickest

basement membrane of our body,9

is a constitutive basement membrane of the

lens. Use of ALC graft for chronic corneal ulcers or as support material in RPE

cell transplantation has been described in literature.9-12

ALC transplantation has

been shown to be effective in resolution of these problems. It does not result in

fibrosis or rejection reaction, and components of humoral immunity do not

participate in immune reaction.13

The presence of ALC itself or some cytokine released may keep fibroblasts from

forming adhesion. The prevention of fibroblast stimulation is beneficial for

maintaining a functional bleb after filtration surgery. Therefore, we will utilize ALC

in trabeculectomy for patients with cataract and glaucoma to prevent post-


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operative adhesion. To the best of our knowledge, there are few studies in

literature evaluating the efficacy of ALC autotransplantation in glaucoma surgery

and no Indian study have been done.


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REVIEW OF LITERATURE

Cataract and glaucoma are the leading causes of blindness worldwide.14,15

These two diseases may occur simultaneously in many patients.

The mainstay of glaucoma treatment is to lower intraocular pressure. Traditional

glaucoma surgeries such a trabeculectomy and tube shunts work well to lower

intraocular pressure and decrease progression of glaucoma, but these

procedures carry significant risk.18,19

Many patients with glaucoma have

concurrent cataracts and some studies have suggested that glaucoma itself is a

risk factor for cataract development.20,21 Glaucoma filtering procedures,

peripheral iridotomy and some glaucoma medications increase the risk of

cataract formation.18,22-25 Historically, patients with moderate to advanced

glaucoma with concurrent cataracts would have either a combined procedure or

a two-stage surgery.19,26-30

Anwar et al32

(1997) studied lens capsule inclusion in trabeculectomy with

cataract extraction. The authors concluded that the combined procedure

appeared to be a sound method of providing visual rehabilitation and adequate

IOP control. The use of the capsular wick seemed to help maintain glaucoma

filtration.

Kiilgaard et al11

(2002) investigated the consequences of transplantation of a new

basement membrane to the subretinal space (SRS) as a substitution of Bruch's

membrane. They found that it is possible to transplant porcine ALC to the SRS of

the pig. ALCs are well-tolerated in the SRS and are covered with well-

differentiated monolayers of host RPE-cells, if Bruch's membrane is left intact.

Lee et al10 (2006) investigated human anterior lens capsule as a potential

replacement for Bruch's membrane as a treatment for age-related macular


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degeneration and find that the lens capsule has the potential to act as a

substitute Bruch's membrane.

Kozak et al9 (2004) studied electron microscopy of anterior lens capsule

allotransplants in chronic corneal ulcers. It was concluded that on the

ultrastructural level, anterior lens capsule allotransplants in mechanically induced

corneal ulcer heal with continuously formed epithelial basement membrane and

numerous hemidesmosomes.

Kozak et al13

(2004) used immunofluorescent analysis to find out in histologic

corneal sections a possible rejection reaction in anterior lens capsule

allotransplantation for chronic corneal ulcers. They preliminarily concluded that

anterior lens capsule allotransplantation for chronic corneal ulcers does not result

in rejection reaction and that components of humoral immunity do not participate

in immune reaction.


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AIM AND OBJECTIVES

To evaluate and compare the type of bleb and IOP reduction in patients of both

the groups after surgery in three months follow-up.

Objectives

1. To evaluate type of bleb formation with and without ALC implant in cataract

with glaucoma.

2. To evaluate/compare IOP control with and without ALC autotransplantation.

3. To compare IOP control and bleb status at 3 months follow-up

4. To evaluate the ocular complications after phacotrabeculectomy and

autotransplantation of ALC in phacotrabeculectomy.


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MATERIALS AND METHODS

Setting: Inpatients, Department of Ophthalmology, University College of Medical

Sciences and Guru Teg Bahadur Hospital, Delhi-110095.

Duration: November 2013 to March 2015

Type of study: Prospective interventional case control study.

Sample size: 62 patients, 31 each in two groups (patients with coexisting

cataract and glaucoma who would require phacotrabeculetomy)

The patients with coexisting cataract and glaucoma will be enrolled in this study

with informed consent (Annexure-1).

Inclusion criteria:

1. All patients with coexisting cataract and glaucoma who would require

phacotrabeculetomy.

2. Any gender

Exclusion criteria:

1. History of uveitis.

2. History of previous ocular surgery.

3. Patient not compliant and not completing the 3 months follow-up.

4. Post traumatic cataract and glaucoma.

5. Patients with Grade-IV cataract and harder cataract.


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Evaluation

History:Detailed history will be taken from all the patients which include historyof any ocular complaints, frequent change of presbyopic glasses, history

suggestive of visual field defects, history of attacks of pain, redness, systemic

complaints or diseases, and family history of ocular or systemic diseases

(Annexure-2).

General p hysical examinat ion: Comprehensive general physical examination

will be subsequently done in all the patients to rule out any gross systemic

disease.

Ocular examinat ion: Detailed ocular examination will be done in all patients with

special emphasis on:

Visual acui ty:The best corrected visual acuity in each eye will be recorded

using Snellens chart.

Local examinat ionof anterior segment including, cornea, anterior chamber

and its depth, iris, pupillary size and reaction, and ocular adnexa will be done

in each case.

Sl i t lamp examinat ion: The techniques of diffuse illumination, focal

illumination and retro illumination will be used and a careful assessment will

be done especially with regards to following criteria :

- Conjunctival hyperemia

- Anterior chamber examination suggestive of a recent or past attack of

uveitis and glucoma.

- Corneal edema and bullous keratopathy

- Iris abnormalities, including diffuse or focal atrophy, posterior

synechiae.

- Pupil - size, shape and reactivity will be examined.

- Lens changes including cataract.

- Central and peripheral anterior chamber (AC) depth. Peripheral AC

depth will be graded using Van Herick technique:


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GRADE 4 OR LARGER - PAC 1 CT

GRADE 3 - PAC = - CT

GRADE 2 - PAC = CT

GRADE 1 - PAC< CT

N. B. PAC= peripheral anterior chamber, CT = corneal thickness.

IOP: Intraocular pressure recording of each eye using Goldmann

applanation tonometer.

Keratometry:Keratometry of each eye to measure corneal curvature using,

Bausch and Lomb type Keratometer.

A-Scan :Axial length of each eye will be measured using A-Scan.

Preparation of human anterior lens capsule

Human ALC will be obtained under sterile condition from the patient when they

received continuous curvilinear capsulorrhexis. The lens epithelial cells will be

scraped off ALC carefully with a lenticular hook under the operating microscope

until ALC completely denuded. ALC will be washed twice with a sterile, balanced

salt solution before use.

Preoperative Treatment:All the subjects undergoing phacotrabeculectomy would be given a standard

regimen consisting of the following:

Eyedrop Moxifloxacin Hydrochloride 0.5% and Ketorolac Tromethamine

0.5%, one drop 6 hourly, one day before surgery

Tablet Ciprofloxacin Hydrochloride 500 mg on the night before and on the

morning of surgery

Tablet Ranitidine 150 mg on the night before and on the morning of

surgery

Tablet Alprazolam 0.25 mg on the night before surgery

Mydriasis will be achieved by instilling eyedrop Tropicamide 0.8% and

Phenylephrine Hydrochloride 5.0%, one drop every 15 min 1 hour prior to

surgery.


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All the surgeries will be performed by the same set of experienced surgeon's,

and followed up in the OPD.

Surgical Technique

All the surgeries will be performed under peribulbar local anaesthesia. A fornix-

based conjunctival flap will be fashioned at the superior position in all the

patients.

The conjunctival flap will be followed by a 2/3 thickness sclero-corneal tunnel,

prepared by dissecting the sclera forward into the clear cornea with a crescent

knife. A small limbal paracentesis will be performed at the 2 o'clock position. The

anterior chamber will then be entered at clear corneal temporal position with the

3.2-mm keratome. The anterior chamber will be immediately deepened with

Viscoelastic substance (Hydroxy Propyl Methyl Cellulose 2%). Routine

phacoemulsification will be followed in all cases using stop and chop technique.

In the ALC group, Human ALC will be obtained under sterile condition from the

patient when they received continuous curvilinear capsulorrhexis. The lens

epithelial cells will be scraped off ALC carefully with a lenticular hook under the

operating microscope until ALC completely denuded. ALC will be washed twice

with a sterile, balanced salt solution before use.

After emulsification of nuclear fragments, irrigation aspiration of residual cortical

matter will be done. A foldable intraocular lens will be put inside the capsular

bag.The pupil will be contracted with 0.01% pilocarpine injection. A

trabeculectomy of 1 x 2 mm will be performed under the same sclero-cornealtunnel with a 15 scalpel and Vannas scissors. A broad base peripheral

iridectomy will be performed, to ensure that iris could not be visualized in the

base of the trabeculectomy opening.


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In the ALC Group, ALC will then be placed under the scleral tunnel and kept it as

flat as possible. The scleral tunnel will be closed with 10/0 nylon suture, taking

the ALC in the suture bite. The conjunctival wound will be closed with 8/0 vicryl

sutures. No antimetabolites were used during or after surgery.

POST-OPERATIVE CARE AND FOLLOW-UP

Posto perative Treatmen t:

Oral antibiotic (tablet Ciprofloxacin Hydrochloride 500mg twice a day) for 5

days

Topical steroid eye drops (Prednisolone Acetate 1%) one drop 4 hourly for 4

weeks

Eyedrop Tropicamide 0.8% and Phenylephrine Hydrochloride 5.0 % one drop

2 times a day for 2 weeks

Eyedrop Moxifloxacin Hydrochloride 0.5% one drop 4 times a day for 1 week

Tropical Steroid eye drops will be tapered gradually and stopped after 8 weeks of

surgery. Subconjunctival steroids, post-operative suture lysis or 5-FU injections

will not be used in either group.

Post-operative evaluation will be conducted on days 1, 7 and months 1 and 3.

The patients, who needed closer follow-up, according to the clinical outcome, will

be evaluated as per need. On each occasion, the patients will be fully examined

under the slit lamp biomicroscopy. The BCVA, IOP, and bleb appearance will be

determined. Any complications of surgery will be noted.

OUTCOME MEASURES

Type of blebin both the groups.

Assessment of IOP reduction in both the groups.

Any other ocular complications in both the groups


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Data management Statistical analysis: chi-square test to compare bleb

formation between two groups. Repeated measures ANOVA for inter and intra

comparison of IOP.

Reason for the sample size: A sample size 31 per group with 80% power and

5% level of significance to detect a difference between phacotrabeculectomy and

phacotrabeculectomy with anterior lens capsule proportion of 0.19 (0.99 in

phacotrabeculectomy and 0.80 in phacotrabeculectomy with anterior lens

capsule) is adequate.

Power of study: 80%

Level of significance: 5%


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REFERENCES

1. Mao LK, Stewart WC, Shields MB. Correlation between intraocular

pressure control and progressive glaucomatous damage in primary open-angle glaucoma. Am J Ophthalmol 1991; 111: 5155.

2. Chauhan BC, Drance SM. The relationship between intraocular pressure

and visual field progression in glaucoma. Graefes Arch Clin Exp

Ophthalmol 1992; 230: 521526.

3. Cairns JE. Trabeculectomy: Preliminary report of a method. Am J

Ophthalmol 1968; 66: 673679.

4. Bindlish R, Condon GP, Schlosser JD, D'Antonio J, Lauer KB, Lehrer R.

Efficacy and safety of Mitomycin-C in primary trabeculectomy.

Ophthalmology 2002; 109: 13361341.

5. Shields MB, Scroggs MW, Sloop CM, Simmons RB. Clinical and

histopathologic observations concerning hypotony after trabeculectomy

with adjunctive mitomycin C. Am J Ophthalmol 1993; 116: 673683.

6. Zacharia PT, Depperman SR, Schuman JS. Ocular hypotony after

trabeculectomy with mitomycin C. Am J Ophthalmol 1993; 116: 314326.

7. Greenfield DS, Suner IJ, Miller MP, Kangas TA, Palmberg PF, Flynn Jr

HW. Endophthalmitis after filtering surgery with mitomycin. Arch

Ophthalmol 1996; 114: 943949.

8. Higginbotham EJ, Stevens RK, Musch DC, Karp KO, Lichter PR,

Bergstrom TJ et al. Bleb related endophthalmitis after trabeculectomy with

mitomycin C. Ophthalmology 1996; 103: 650656.

9. Kozak I, Trbolova A, Zibrin M, Komorova T, Kolodzyeiski L, Juhas T.

Electron microscopic study of anterior lens capsule allotransplants in

chronic corneal ulcers. Cornea 2004; 23: 797803.

10. Lee CJ, Vroom JA, Fishman HA, Bent SF. Determination of human lens

capsule permeability and its feasibility as a replacement for Bruch's

membrane. Biomaterials 2006; 27: 16701678.


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11. Kiilgaard JF, Wiencke AK, Scherfig E, Prause JU, La Cour M.

Transplantation of allogenic anterior lens capsule to the subretinal space

in pigs. Acta Ophthalmol Scand 2002; 80: 7681.

12. Hartmann U, Sistani F, Steinhorst UH. Human and porcine anterior lens

capsule as support for growing and grafting retinal pigment epithelium and

iris pigment epithelium. Graefes Arch Clin Exp Ophthalmol 1999; 237:

940945.

13. Kozak I, Trbolova A, Rosocha J, Jautova J, Juhas T, Ledeckv V.

Immunofluorescent analysis of anterior lens capsule allotransplantation for

chronic corneal ulcers. Cesk Slov Oftalmol 2004; 60: 261266.

14. West S. Epidemiology of cataract: accomplishments over 25 years and

future directions. Ophthalmic Epidemiol. 2007;14:1738.

15. Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol.

1996;80:38993.

16. Foroozan R, Levkovitch-Verbin H, Habot-Wilner Z, Burla N. Cataract

Surgery and Intraocular Pressure. Ophthalmology. 2008;115:1048.

17. Poley BJ, Lindstrom RL, Samuelson TW. Long-term effects of

phacoemulsification with intraocular lens implantation in normotensive and

ocular hypertensive eyes. J Cataract Refract Surg. 2008;34:73542.

18. Jampel H. Trabeculectomy: more effective at causing cataract surgery

than lowering intraocular pressure? Ophthalmology 2009;116(2):173-4.

19. Caprioli J, Park HJ, Weitzman M. Temporal corneal phacoemulsification

combined with superior trabeculectomy: a controlled study. Trans Am

Ophthalmol Soc. 1996;94:45163. discussion 63-8.

20. Leske MC, Connell AM, Wu SY, Hyman LG, Schachat AP. Risk factors for

open-angle glaucoma. The Barbados Eye Study. Arch Ophthalmol.

1995;113:91824.

21. Ughade SN, Zodpey SP, Khanolkar VA. Risk factors for cataract: a case

control study. Indian J Ophthalmol. 1998;46:2217.


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22. Husain R, Aung T, Gazzard G, Foster PJ, Devereux JG, Chew PT, et al.

Effect of trabeculectomy on lens opacities in an East Asian population.

Arch Ophthalmol. 2006;124:78792.

23. Lim LS, Husain R, Gazzard G, Seah SK, Aung T. Cataract Progression

after Prophylactic Laser Peripheral Iridotomy Potential Implications for the

Prevention of Glaucoma Blindness. Ophthalmology. 2005;112:13559.

24. Bobrow JC. Factors Influencing Cataract Formation After Nd: YAG Laser

Peripheral Iridotomy. Trans Am Ophthalmol Soc. 2008;106:937.

25. ass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP,

et al. The Ocular Hypertension Treatment Study a randomized trial

determines that topical ocular hypotensive medication delays or prevents

the onset of primary open-angle glaucoma. Arch Ophthalmol.

2002;120:70113.

26. Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M, et al.

Reduction of intraocular pressure and glaucoma progression: results from

the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120:126879.

[PubMed: 12365904]

27. Caprioli J, Park HJ, Kwon YH, Weitzman M. Temporal corneal

phacoemulsification in filtered glaucoma patients. Trans Am Ophthalmol

Soc. 1997;95:15367.

28. Samuelson TW. Management of coincident cataract and glaucoma. Curr

Opin Ophthalmol. 1993;4:906.

29. Wedrich A, Menapace R, Radax U, Papapanos P. Long-term results of

combined trabeculectomy and small incision cataract surgery. J Cataract

Refract Surg. 1995;21:4954.

30. Lederer CM., Jr Combined cataract extraction with intraocular lens implant

and mitomycin-augmented trabeculectomy. Ophthalmology.

1996;103:1025.

31. Cantor LB, Mantravadi A, WuDunn D, Swamynathan K, Cortes A.

Morphologic classification of filtering blebs after glaucoma filtration


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surgery: the Indiana Bleb Appearance Grading Scale. J Glaucoma. 2003

Jun;12(3):266-71.

32. Lu D, Liu W, Li H, Ji J. The application of human anterior lens capsule

autotransplantation in phacotrabeculectomy: a prospective, comparative

and randomized clinical study Tianjin Medical University Eye Center,

Tianjin, China. Eye (Lond) 2009;23(1):195-201.
http://www.ncbi.nlm.nih.gov/pubmed?term=Lu%20D%5BAuthor%5D&cauthor=true&cauthor_uid=18404160http://www.ncbi.nlm.nih.gov/pubmed?term=Liu%20W%5BAuthor%5D&cauthor=true&cauthor_uid=18404160http://www.ncbi.nlm.nih.gov/pubmed?term=Li%20H%5BAuthor%5D&cauthor=true&cauthor_uid=18404160http://www.ncbi.nlm.nih.gov/pubmed?term=Ji%20J%5BAuthor%5D&cauthor=true&cauthor_uid=18404160http://www.ncbi.nlm.nih.gov/pubmed/?term=D+Lu%2C+W+Liu%2C+H+Li+and+J+Ji+2009http://www.ncbi.nlm.nih.gov/pubmed/?term=D+Lu%2C+W+Liu%2C+H+Li+and+J+Ji+2009http://www.ncbi.nlm.nih.gov/pubmed?term=Ji%20J%5BAuthor%5D&cauthor=true&cauthor_uid=18404160http://www.ncbi.nlm.nih.gov/pubmed?term=Li%20H%5BAuthor%5D&cauthor=true&cauthor_uid=18404160http://www.ncbi.nlm.nih.gov/pubmed?term=Liu%20W%5BAuthor%5D&cauthor=true&cauthor_uid=18404160http://www.ncbi.nlm.nih.gov/pubmed?term=Lu%20D%5BAuthor%5D&cauthor=true&cauthor_uid=18404160


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ANNEXURE-1

INFORMED CONSENT FORM

I _______________________________ son/daughter/wife of _____________________resident of ____________________________________________ give my full, free andvoluntary consent to be included as a subject in the study entitled Comparativeevaluation of phacotrabeculectomy versus phacotrabeculectomy with autologousanterior lens capsule application in the success of trabeculectomy surgery . Ihave been explained and to my full satisfaction, the aim and nature of the study andrisks and benefits. I have also been explained that my confidentiality will be maintainedand all the investigations / interventions will be carried out only after my consent isobtained. I am aware of my right to opt out of the study at any point without giving anyreason, and without penalty or loss of routine care benefits.

Patients Name Witness name Doctors name

Signature / Thumb Impression* Signature Signature

Date & Time: Date & Time: Date & Time:

+Mi i {j

]/]/{i x

+{x {h ixj + SUE { "kY; f;kifj.kke dh lQyrk esa lgk;d ds rkSj ij vkWVksyksxl ysal dSIlwy ds mi;ksx dslkFk QsdksVkcsD;wysDVeh cuke QsdksVkcsD;wysDVeh dk rqYkukRed

ewY;kadu x E +vx i x E i ni/ni

*


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E


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ANNEXURE - 2

CASE RECORD FORM

Name: Age/Sex: C.R. No: Group :

Address:______________________________________________________________

History:

Chief complaints:

History of present illness:

Eyeache/ headache/ coloured haloes/ watering/ redness/ field loss

Spectacle wear: Since

Number

Frequent changes

Improvement

Treatment History:

Drugs

Duration

Improvement

Laser treatment

History of glaucoma surgery

Family History: Glaucoma / Cataract

Past History:

Hypertension/ diabetes/ TB/ previous cataract or glaucoma surgery

EXAMINATION:

General Physical Examination

Systemic Examination (Chest/ CVS/ Abdomen/ CNS)


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OCULAR EXAMINATION:

Parameter Right Left

Visual acuity

Refraction

Slit lamp examination

Conjunctiva

Cornea

Haze/ opacity/ edema

Pigment / KPs

Anterior chamber

AC depth (Van Hericks)

Iris

Atrophy - Diffuse

- Patchy

- Sphincter

Pattern

Posterior synaechiae

Peripheral Iridectomy

Patent / not

Site

Duration


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Pupils Size

Shape

Reaction

Lens

Grading of cataract -

Fundus Examination -

IOP (Applanation Tonometry)

Keratometry

K1

K2

Axial Length (A-Scan)

Final Diagnosis:


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Post-op status

1st

day 7th

day 1 month 3 month

Bleb status

IOP

Visual acuity

Cells and flare

AC depth

Any symptom

Conjunctivasurrounding the

bleb

Any othercomplications


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TABLE 1

Indiana Bleb Grading System31

Grade I Grade II Grade III Grade IV

Bleb height Flat Low Medium High

Horizontal extent 2-4 hr

Vascularity White &avascular

Cystic & avascular(with microcyst)

Mild to moderatevascularity

Extensive vascularity


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ANNEXURE-3

UNIVERSITY COLLEGE OF MEDICAL SCIENCES ANDGURU TEG BAHADUR HOSPITAL

UNIVERSITY OF DELHI, DELHI-110095Patients Information sheet for participation in the research project

Date: Serial No.

We invite you to participate in research project on Comparative evaluation ofphacotrabeculectomy versus phacotrabeculectomy with autologous anterior lens capsuleapplication in the success of trabeculectomy surgery. Your consent for participation as astudy subject is required as a mandatory requirement for research involving human subjects. Theaims and objectives of the study and methodology to be followed are given below, so that yougive consent after being fully informed. You are free to ask any question and seek clarification.

Study Title: Comparative evaluation of phacotrabeculectomy versusphacotrabeculectomy with autologous anterior lens capsule applicationin the success of trabeculectomy surgery

Student: Dr. Sabitabh Kumar (Mob: 9968474960)

Supervisor: Dr. G.K. DasProfessorDepartment of OphthalmologyUCMS & GTB Hospital, Delhi

Co-Supervisor: Dr. P.K. SahuProfessorDepartment of OphthalmologyUCMS & GTB Hospital, Delhi

Dr. Vinod KumarAssistant Professor,Department of Ophthalmology,UCMS & GTB Hospital, Delhi

Dr. Bhuvan ChananaAssistant Professor,Department of Ophthalmology,UCMS & GTB Hospital, Delhi

Why this research work is necessary?Cataract with glaucoma is one of the major causes of blindness. Cataract with glaucoma can beoperated at once. There are many methods to operate them together with different techniques.New technique with use of autologous lens capsule is used to aid in filtration, but data ofautologous lens capsule use is very limited in the role of phacotrabeculectomy surgery. Thisresearch may indicate the direction in which autologous lens capsule is useful in trabeculectomysurgery and it will help in treatment.

MethodologyAfter taking written informed consent, detailed history and complete examination including ocularexamination by slit lamp, IOP measurement, gonioscopy, fundus evaluation will be done. Theresult of this research can be published in any journal or can be discussed in any scientificmeetings. Your confidentiality will be maintained.


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new protocol 3.docx

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