RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE – 11

SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE DR BHAGYALAKSHMI K

AND ADDRESS ROOM NO 309,

(in block letters) VISHRANTHI DHAMA, FORT,

BANGALORE 560002

2. NAME OF THE INSTITUTION BANGALORE MEDICAL COLLEGE

AND RESEARCH INSTITUTE,

BANGALORE.

3. COURSE OF STUDY AND M.S. OPHTHALMOLOGY

SUBJECT

4. DATE OF ADMISSION TO THE 28TH MAY 2010

COURSE

5. TITLE OF THE TOPIC STUDY OF FEASIBILITY OF

TOPICAL TACROLIMUS 0.03%

OINTMENT IN INTRACTABLE

ALLERGIC CONJUNCTIVITIS AT

MINTO AND BOWRING & LADY

CURZON HOSPITAL, BANGALORE

6. BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY

Allergic conjunctivitis is one of the most common benign external ocular conditions encountered in general ophthalmic practice.1 Allergic eye disease is estimated to affect 20% of population world wide.2 Infrequently a severe chronic form can be debilitating and vision threatened when corneal surface is disrupted.1,3 Histologically eosinophils, mast cells, neutrophils and activated T cells are seen in conjunctival cytology.4 Treatment is usually based on eye drops containing anti histamines, mast cell stabilizers or dual action agents which is often insufficient necessitating the addition of

steroids.1,3-5 However the risk of glaucoma, cataract and super infection limits the use of steroids to short course.

Tacrolimus also known as FK–506 is a macrolide derivative with immunomodulatory and anti-inflammatory activity. Produced by the fungus Streptomyces tsukubaenis, it suppresses T cell activation and IL-2 production by binding to an immunophilin and inhibiting the enzymatic activity of calcineurin.6 Hence this study is undertaken to study the potential feasibility of commercially available 0.03% tacrolimus ointment in conjunctival sac for the treatment of patients with intractable allergic conjunctivitis.

2. REVIEW OF LITERATURE

Liat Atlas Fox, et al studied the feasibility of tacrolimus 0.03% dermatologic ointment in the treatment of intractable allergic conjunctivitis. They concluded that tacrolimus 0.03% ointment is effective well tolerated and safe.1

Trocme, et al studied the immunologic spectrum of five basic types of ocular allergy and the prevalence. They concluded that ocular allergic eye disease is a common problem affecting about 20% of population world wide and the differences and similarities observed might help to better treat the patients.2

.

Pakit Vichyanond, et al studied result of novel therapy with 0.1% topical ophthalmic FK 506 ointment, results indicated a highly favourable response in vernal keratoconjunctivitis & concluded that lower concentration of FK -506 can be tried in future studies. Absorption of FK-506 from conjunctiva was negligible as observed from skin of patients with atopic dermatitis.3

Hannele M, et al studied effect of tacrolimus 0.03% ointment on conjunctival cytology in patients with severe atopic blepharo conjunctivitis. They concluded that tacrolimus ointment is safe and effective treatment for atopic blepharo conjunctivitis. Regular treatment of eyelids once daily may lead to clinical and cytological improvement of conjunctivitis.4

George D Kymionis, et al studied effect of Tacrolimus 0.03% ointment for treatment of Giant papillary conjunctivitis. They concluded that tacrolimus is effective treatment for severe Giant papillary conjunctivitis.5

Poorna Abeysiri, et al studied the use of topical tacrolimus 0.1% skin ointment for anterior segment inflammations. They concluded that it has a role for treatment for steroid resistant cases of vernal keratoconjunctivitis and atopic keratoconjunctivitis.6

3. AIMS AND OBJECTIVES OF STUDY

To study the feasibility of application of commercially available tacrolimus 0.03% dermatologic ointment into the conjunctival sac for the treatment of patients with intractable allergic conjunctivitis.1

7. MATERIALS AND METHODS

7.1 SOURCE OF DATA

Patients attending Minto Ophthalmic Hospital and Bowring and Lady Curzon Hospital during the period of October 2010 to October 2011

7.2 METHOD OF COLLECTION OF DATA

It is a prospective interventional hospital based study of 30 intractable allergic conjunctivitis patients. Existing ocular treatment have to be discontinued at enrollment. Tacrolimus 0.03% ointment shall be applied into conjunctival sac of affected eyes once daily for 10 weeks followed by a 2 weeks washout period. Conjunctivitis severity shall be recorded with a composite subjective & objective score at each visit. Patients will be followed up twice a week in the first week, weekly for next three visits and once in two weeks for another four visits.

INCLUSION CRITERIA :

• Subjects both males and females >5years of age suffering from intractable allergic conjunctivitis

EXCLUSION CRITERIA :

• Pregnancy

• Breast feeding

• History of herpetic eye disease

• Transplant patients

• Concomitant administration of drugs inhibiting cytochrome CYP3A4

• Hypersensitivity to macrolides

• Adnexal and ocular infection

STATISTICAL METHOD : paired t test

3. DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? ( IF SO DESCRIBE BRIEFLY)

Yes the study involves the following investigations and interventions on

patients

- visual acuity testing for distance and near

- intra ocular tension

- slit lamp biomicroscopic examination

- direct ophthalmoscopy

- pre and post treatment slit lamp assisted external ocular photography

4. HAS THE ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3? Yes

8. LIST OF REFERENCES

JOURNAL REFERENCES

1. L. A. Fox , Y Barkana, V Iskhakov and Svetlana R .Topical tacrolimus 0.03%

ointment for intractable allergic conjunctivitis. Current Eye Research .

2008;33:545-549.

2. Trocme SD, Sra K K. Spectrum of ocular allergy. Curr Opin Allergy Clin

Immunol. 2002;2:423-427

3. Pakit V, Chiraphan T, Puttachart D, Orathai J,Nualanong V & Panida K.

Vernal keratoconjunctivitis; Result of a novel therapy with 0.1% topical

ophthalmic FK 506 ointment. J Allergy Clin Immunol. 2004;113:355-358.

4. Hannele M.V., Sakari R, Marjatta K and Osmo Kori. Effect of tacrolimus

ointment on conjunctival cytology in patients with atopic blepharoconjunctivitis

Acta Ophthalmol Scand. 2006;84:693 – 695.

5. George D.k., David G, Takesh ide and Sonia. Tacrolimus ointment 0.03% for

treatment of Giant papillary conjunctivitis. Cornea. 2008;27:228-229.

6. Poorna A, Nichol as RJ and Anthony C B Molteno . Use of 0.1% topical

tacrolimus ointment for anterior segment conditions a case series.

Ophthalmology and eye diseases 2010;2:5-8.

9. SIGNATURE OF CANDIDATE

10. REMARKS OF THE GUIDE

Allergic conjunctivitis is a common clinical occurrence . Despite its benign natural course sight threatening complications occur in some forms of allergic conjunctivitis. This study under my guidance will help to know the advantages of topical tacrolimus 0.03% ointment in intractable allergic conjunctivitis.

11 NAME AND DESIGNATION OF THE

11.1 GUIDE DR SHIVKUMAR

M.B.B.S., M.S., D O M S,

PROFESSOR OF OPHTHALMOLOGY,

BOWRING AND LADY CURZON

HOSPITAL,

BANGALORE MEDICAL COLLEGE

AND RESEARCH INSTITUTE,

BANGALORE.

11.2 SIGNATURE

11.3 CO GUIDES IF ANY NONE

11.4 SIGNATURE

11.5 HEAD OF THE DEPARTMENT DR RAVIPRAKASH,

M.B.B.S., M.S.(OPH)

MINTO OPHTHALMIC HOSPITAL

AND REGIONAL INSTITUTE

BMC & RI

BANGALORE.

11.6 SIGNATURE

11.7 DIRECTOR DR SRI PRAKASH

MOH&RI M.B.B.S., M.S.(OPH)

MINTO OPHTHALMIC HOSPITAL

AND REGIONAL INSTITUTE

BMC AND RI

BANGALORE 560002

11.8 SIGNATURE

11.9 REMARKS OF THE DEAN AND DIRECTOR

BMC&RI

11.10 SIGNATURE

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