Rajiv Gandhi University of Health Sciences, Karnataka s20

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 NAME OF THE CANDIDATE & Dr. SHAMSHER AHMED PUNEKAR ADDRESS S/O R. M. PUNEKAR (IN BLOCK LETTERS) H NO 117, I FLOOR KP2, HEMANTH NAGAR KESHWAPUR HUBLI – 580023

2 NAME OF THE INSTITUTION BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE BANGALORE -560001

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

SUBJECT

4 DATE OF THE ADMISSION TO 23rd MAY 2009

THE COURSE

5 TITLE OF THE TOPIC “STUDY OF SAFETY AND EFFICACY OF SUPRATARSAL INJECTION OF TRIAMCINOLONE ACETONIDE IN THE MANAGEMENT OF REFRACTORY VERNAL KERATOCONJUNCTIVITIS”

6 BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY

Vernal keratoconjunctivitis(VKC) is a severe perennial or seasonal form of allergic conjunctivitis predominantly affecting children and young adults. 80% of the patients are below 14 years of age and boys are usually more affected at 2:1 ratio. In majority of children, average duration of disease ranges from 2 to 10years.1

Milder cases of VKC can be treated with cold compresses, artificial tears, topical vasoconstrictors or topical anti-histamines.2 However conventional methods of treatment may not be effective in patients with severe VKC characterized by giant papillae, severe limbal involvement or corneal shield ulcer.1

Recently, a number of new therapeutic agents have been used in refractory VKC. These include topical NSAID`S, topical mast cell stabilizers(Nedocromil, Lodoxamide), topical immunomodulators (Cyclosporine) and topical anti- histamines (Levocabastine).1 However most of these newer treatment modalities have been found relatively ineffective.2

More recently, successful use of supratarsal injection of coticosteroids has been reported in severe and refractory VKC.1

6.2 REVIEW OF LITERATURE

 Study by Jagadish Bhatia, Najmi Rahman, Muhammad Naqaish Sadiq and Mathew Varghese stated that supratarsal injection of Triamcinolone acetonide is safe and effective therapeutic approach for refractory VKC.1

 Study by Dawood Aghadoost and Mohammad Zare highlights the rapid and dramatic symptomatic and clinical response and lack of complications with supratarsal injection of Triamcinolone acetonide when used for refractory VKC.2

 Study by Holsclaw DS, Whitcher JP, Wong IG and Margolis TP concluded that supratarsal injection of corticosteroid may be a valuable therapeutic approach to treat refractory vernal keratoconjunctivitis.3

 Study by Saini JS and Pandey SK reflects the safety and efficacy of supratarsal injection of corticosteroids in recalcitrant VKC in terms of symptomatic relief and inducing remission.4

 Study by S Singh, V Pal and CS Dhull concluded that,supratarsal injection of corticosteroids is very effective for temporary suppression of severe inflammation associated with VKC.5

6.3 OBJECTIVES OF THE STUDY

To study the safety and efficacy of supratarsal injection of Triamcinolone acetonide in the management of refractory VKC. 7 MATERIALS AND METHODS

7.1 SOURCE OF DATA

All Patients attending OPD at ophthalmic department of Bowring and Lady Curzon Hospital and Minto Ophthalmic Hospital Bangalore.

7.2 METHOD OF COLLECTION OF DATA

It is a hospital based, prospective, interventional case study of 50 patients with

severe VKC refractory to conventional methods of treatment during the study period of 2 years from november 2009 to october2011. All subjects will undergo complete ocular examination before intervention. Informed consent will be taken prior to intervention after complete description of procedure and its purpose to the patient and their parents.

For the selected patients Triamcinolone acetonide 0.5 ml (20mg) will be injected in the potential space between upper palpebral conjuctiva and Muller`s muscle, 1 mm superior to the upper edge of tarsus with a 27 gauge needle after 4% xylocaine is instilled into the eye 3 times at interval of 2 minutes. No eye dressing or patching will be used after giving the injection.

Photograph of every eye will be taken before injection and then on every follow-up visit. A row of five cobblestones in the centre of upper tarsal plate will be measured and recorded.

Patients will be followed-up in the first week and fourth week after injection and thereafter at monthly intervals for six months. Symptoms will be recorded subjectively and the size of papillae will be evaluated and documented at each visit.

Treatment will be considered successful if the symptoms reduce by atleast 50% of pre-treatment severity and/or 50% reduction in the maximum pre-treatment size of cobble stone papillae. Disease recurrence will be determined if symptoms or maximum papillae size increased and attained or exceeded the pre-treatment levels.

All patients will be observed for any side effects of steroid injection namely de- pigmentation of eyelid skin, infection, motility disturbance, raised intra-ocular pressure and clarity of crystalline lens on every visit.

The study data will be entered in Microsoft excel spread sheet. Measures of central tendency and appropriate statistical tests will be used to analyse the data.

INCLUSION CRITERIA All patients with advanced and refractory VKC not responding or inadequately responding to month long maximum topical therapy consisting of combination of NSAID`s, mast cell stabilizers, antihistamine and corticosteroid.

EXCLUSION CRITERIA

a. Patients with active ocular infection b. Patients receiving concurrent treatment for other allergic disorders c. Patients previously treated with oral prednisolone, topical cyclosporine and topical lodoxamide. d. Patients with history of contact lens wear e. Patients with developmental cataracts f. Patients with congenital and developmental glaucoma g. Patients who are unable to communicate because of age and intellect h. Patients unwilling for the procedure 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS TO BE CONDUCTED ON PATIENTS, OTHER HUMAN OR ANIMAL? IF SO PLEASE DESCRIBE BRIEFLY.

INVESTIGATIONS AND INTERVENTIONS

a. Visual acuity testing b. Refraction c. Evaluation of ocular tension by Goldmann`s applanation tonometry d. Lacrimal syringing e. Slit lamp bio-microscopy f. Direct ophthalmoscopy, Indirect ophthalmoscopy. g. Supratarsal injection of 0.5 ml of Triamcinolone acetonide under appropriate anaesthesia.

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

8 LIST OF REFERENCES:

1. Bhatia J, Rahman N, Sadiq MN, Varghese M. Safety and efficacy of supratarsal injection of Triamcinolone in the management of refractory Vernal Keratoconjunctivitis. Rawal Med J 2008; 2008: 235-238.

2. Aghadoost D, Zare M. Supratarsal injection of Triamcinolone acetonide in the treatment of refractory vernal keratoconjunctivitis. Arch of Iranian Med. 2004; 7(1): 41-43.

3. Holsclaw DS, Whitcher JP, Wong IG, Margolis TP. Supratarsal injection of cortico steroid in the treatment of refractory vernal keratoconjunctivitis. Am J Ophthalmol. 1996; 121: 243 – 249.

4. Saini JS, Gupta A, Pandey SK, Gupta V, Gupta P. Efficacy of supratarsal

dexamethasone v/s triamcinolone injection in recalcitrant vernal keratoconjunctivitis. Acta Ophathalmol Scand 1999; 77: 515 –518.

5. Singh S, Pal V, Dhull CS. Supratarsal injection of corticosteroids in the treatment of refractory vernal keratoconjunctivitis. Indian J Ophthalmol 2001; 49: 241-245.

6. Sethi HS, Waugh VB, Rai HK. Supratarsal injection of corticosteroids in the treatment of refractory vernal keratoconjunctivitis. Indian Ophthalmol 2002Jun; 50(2): 160-161.

7. Buckley RJ. Vernal keratoconjunctivitis. Int Ophthalmol Clin 1988; 28: 303 –308.

8. Allan Smith MR. Vernal keratoconjunctivitis: Duanne`s clinical Opthalmology. 2nd ed. Vol. 4. Philadelphia: Lippincot – Raven; 1991: 1– 8.

9. Sihota R, Tandon R. Chapter 14: Diseases of conjunctiva, “Parson`s

9 SIGNATURE OF CANDIDATE:

Dr. SHAMSHER AHMED PUNEKAR

10 REMARKS OF THE GUIDE:

Vernal keratoconjunctivitis (VKC) is a severe perennial or seasonal form of allergic conjunctivitis predominantly affecting children and young adults. The conventional methods of treatment of severe VKC may not be effective in patients

with giant papillae, severe limbal involvement.

Hence the study of the safety and efficacy of the effect of supratarsal injection

of intermediate acting steroid triamcinolone acetonide in the management of

refractory vernal keratoconjunctivitis.

Some earlier studies have shown, after 12 months of follow-up none of the patients developed any side effect or complications of steroid injection. 11.1 NAME AND DESIGNATION OF GUIDE: Dr SHIVA KUMAR M.B.B.S., M. S. (OPHTH), D.O.M.S. PROFESSOR DEPARTMENT OF OPHTHALMOLOGY BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE

BANGALORE –560001 11.2 SIGNATURE OF GUIDE:

11.3 CO-GUIDE(IF ANY): NONE

11.4 SIGNATURE OF CO-GUIDE:

11.5 NAME & DESIGNATION OF HOD:

Dr SRIPRAKASH K.S. M.B.B.S., M. S. (OPHTH)

MEDICAL SUPERINTENDENT

MINTO OPHTHALMIC HOSPITAL PROFESSOR AND HOD

DEPARTMENT OF OPHTHALMOLOGY BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE BANGALORE – 560002. 11.6 SIGNATURE OF HOD:

12.1 REMARKS OF CHAIRMAN AND PRINCIPAL:

12.2 SIGNATURE OF PRINCIPAL: