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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE

KARNATAKA

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT

FOR DISSERTATION

| | |

|1.NAME OF THE CANDIDATE |Dr.AMUDHA.A |

|AND ADDRESS |ROOM NO. 9, |

|(IN BLOCK LETTERS) |POST GRADUATE AND INTERNS HOSTEL FOR WOMEN, |

| |OPPOSITE NANJABAHADDUR CHOULTRY,VINOBHA ROAD, |

| |MMC & RI, MYSORE. |

| | |

|2.NAME OF THE INSTITUTION |MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE. |

| | |

|3.COURSE OF THE STUDY |M.S. OPHTHALMOLOGY |

|AND SUBJECT | |

| | |

|4.DATE COMMENCEMENT OF |1-07-2013 |

|THE COURSE | |

| |“ A COMPARATIVE STUDY OF THE EFFICACY |

|5.TITLE OF THE TOPIC |OF TOPICAL LOTEPREDNOL ETABONATE 0.5% |

| |AND FLUOROMETHOLONE 0.1% IN THE |

| |TREATMENT OF |

| |VERNAL KERATOCONJUNCTIVITIS”. |

6. BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY:

The conjunctiva of the eye being similar to the nasal mucosa is equally susceptible to allergic reactions.1 Allergic conjunctivitis is a Type I (immediate) hypersensitivity reaction, mediated by degranulation of mast cells in response to the action of IgE, however there is evidence of an element of Type IV hypersensitivity in at least some forms.2

The various types of allergic conjunctivitis are - seasonal allergic conjunctivitis (SAC), perennial allergic conjunctivitis (PAC), vernal keratoconjunctivitis (VKC), atopic keratoconjunctivitis (AKC) and giant papillary conjunctivitis (GPC).3

Vernal keratoconjunctivitis (VKC) is a chronic, bilateral, at times asymmetrical, seasonally exacerbated, allergic inflammation of the ocular surface, involving tarsal and ⁄ or bulbar conjunctiva. It was first mentioned in the ophthalmic literature as conjunctiva lymphatica more than 150 years ago. It is also called as spring catarrh, phlyctenula pallida, circumcorneal hypertrophy, recurrent vegetative conjunctiva, verrucosa conjunctiva and aestivale conjunctiva. VKC usually starts before the age of 10 years and is more common among males, with the male to female ratio varying from 4: 1 to 2: 1 and generally resolves after puberty.4

The characteristic sign is the presence of giant papillae (cobblestone) on upper tarsal conjunctiva. It is also associated with severe itching; incapacitating photophobia and trantas dots. Cornea may be affected and can lead to central corneal scarring.1 The main treatment options include topical decongestants, antihistaminics, mast cell stabilizers and anti-inflammatory agents.5

While the term “vernal” suggests a seasonal pattern of disease, VKC is often persistent in warm, tropical climates around Asia and up to a quarter of seasonal cases evolve into perennial disease 3 years from the onset of disease, further up to 85% of patients with VKC will require corticosteroids at some point during the course of their illness.6

Topical steroids are effective in ocular allergy, but their use should be judicious since they carry serious side effects like cataract development, raised IOP, etc.7 The basic principle of treatment of vernal keratoconjunctivitis is optimal control of symptoms with a minimum of toxic side effects resulting from prolonged use of medication.8 This is especially applicable when dealing with steroids.

This has led to the development of modified 'soft'/ 'smart' ophthalmic corticosteroid formulations that retain their anti-inflammatory mechanism of action with an improved safety profile.9 Two such topical steroid preparations are loteprednol etabonate and fluorometholone.

Further any medications in terms of their clinical efficacy and side effects vary from individual to individual.10 In view of these aspects and since there is limited data available that compares the use of loteprednol etabonate and fluorometholone in vernal keratoconjunctivitis, we have proposed to compare the effectiveness of topical loteprednol etabonate 0.5% with fluorometholone 0.1% in vernal keratoconjunctivitis patients at K.R.Hospital, Mysore.

6.2 REVIEW OF LITERATURE:

• Loteprednol etabonate (LE) is an ester corticosteroid with a high therapeutic index that contains an ester, rather than a ketone, at carbon-20 of the prednisolone core structure. Because of its rapid de-esterification to inactive metabolites, LE appears to have an improved safety profile compared with ketone corticosteroids, and may be more suitable than ketone corticosteroids for the treatment for ocular inflammatory conditions in which long-term therapy is necessary.11

• The C-20 ester corticosteroid loteprednol etabonate is less likely to elevate intraocular pressure. Also the ketone at the C-20 position in older steroid preparations has been implicated in the formation of cataract, while nonketonic corticosteroids like loteprednol etabonate do not form Schiff base intermediates with lens proteins, which is a common first step in cataractogenesis.12

• Fluorometholone (21-desoxy-9 -fluoro-6 methyl prednisolone) is an anti-inflammatory steroid with structural characteristics in common with progesterone and found to have anti-inflammatory activity 25 to 50 times that of hydrocortisone, but without the same propensity to raise intraocular pressure. This effect is thought to be related to the chemical structure of fluorometholone, specifically, the deoxygenation at the C21 position.13

• In a study done by Öner V et al to compare the efficacy and safety of loteprednol etabonate 0.5 % with fluorometholone in patients with vernal keratoconjunctivitis, found that after 28 days of treatment, the signs and symptoms of VKC was less well controlled in the fluorometholone group compared to loteprednol etabonate. Overall they concluded that loteprednol etabonate was better than fluorometholone in terms of efficacy.14

• Ilyas H et al in a retrospective review to assess the long term safety of loteprednol etabonate 0.2% in 397 patients with SAC and PAC , established that loteprednol etabonate 0.2% produced no adverse effects like steroid-induced intraocular pressure increase, cataract formation, and any other possible topical steroid-induced adverse events in 159 patients who had used it for a period of more than 12 months.15

• Noble S et al, while reviewing various clinical trials regarding the use of loteprednol etabonate in reducing ocular inflammation in conditions like cataract surgery, seasonal allergic conjunctivitis, contact lens wear, etc, have observed that unlike prednisolone acetate, loteprednol etabonate did not significantly increase IOP in a small randomised crossover study even in known steroid responders. They have also suggested that the place of loteprednol etabonate in clinical practice cannot be properly assessed until direct efficacy comparisons with other active treatments are done.16

6.3 OBJECTIVES OF THE STUDY

1) To compare the effectiveness of loteprednol etabonate 0.5% and fluorometholone 0.1% in the management of vernal keratoconjunctivitis.

7. MATERIALS AND METHODS

7.1 SOURCE OF DATA: Outpatients with signs and symptoms of vernal keratoconjunctivitis attending the department of Ophthalmology, K.R. Hospital, Mysore.

7.2 METHODS OF COLLECTION OF DATA

STUDY DESIGN: Comparative study

SAMPLE SIZE: 100

SAMPLING METHOD: Non random purposive sampling

INCLUSION CRITERIA:

1) Patients of both sexes in the age group of (5-20 years) with the signs and symptoms of vernal keratoconjunctivitis.

2) Vernal keratoconjunctivitis patients who are already on treatment with other drugs like prednisolone and olopatadine after a washout period of 4 weeks.

EXCLUSION CRITERIA:

1) Vernal keratoconjunctivitis patients with shield ulcer with/without secondary infections.

2) Vernal keratoconjunctivitis patients with active uveitis.

3) Vernal keratoconjunctivitis patients with giant papillae.

METHOD OF STUDY: Data will be collected using a detailed proforma from patients meeting the inclusion and exclusion criteria of the study by means of personal interview with the patients/patient’s attendant after obtaining the informed consent. Complete ocular examination including slit lamp examination, visual acuity assessment with Snellen’s chart, intraocular pressure measurement and other relevant investigations will be done. Patients will be allotted to either of the two arms of treatment (i.e. loteprednol etabonate 0.5% or fluorometholone 0.1%). Subjective and objective assessments of the signs and symptoms of vernal keratoconjunctivitis would be done using standard scoring methodologies. Patient’s clinical responses to the treatment would be analysed at 7, 14, 21 and 28 days post treatment, through appropriate follow-up visits.

STATISTICAL METHOD USED: Descriptive statistics, contingency table analysis, student’s t test, repeated measure ANOVA.

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONAL INTERVENTION TO BE CONDUCTED ON PATIENTS OR ANY OTHER HUMAN BEINGS OR ANIMALS? IF SO, DESCRIBE BRIEFLY - YES

Following investigations will be done wherever indicated

1) Visual acuity assessment by Snellen’s chart

2) Slit lamp examination

3) Intraocular pressure measurement by I-care tonometry.

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION?

YES (Copy enclosed)

7.5 DURATION OF STUDY: January 2014 to January 2015

8. LIST OF REFERENCES

1) Friedlaender MH. Ocular allergy. In: Copeland RA and Afshari NA, editors. Copeland and Afshari’s principles and practice of cornea – volume 1, 1st edn.: Jaypee; 2013. p. 377-86.

2) Kanski JJ and Bowling B. Clinical Ophthalmology: A Systematic Approach, 7th edn.: Elsevier; 2013. p. 144-52.

3) Mishra GP, Tamboli V, Jwala J and Mitra AK. Recent patents and emerging therapeutics in the treatment of allergic conjunctivitis. Recent Pat Inflamm Allergy Drug Discov. 2011; 5(1):26-36.

4) Kumar S. Vernal keratoconjunctivitis: a major review. Acta Ophthalmol.2009; 87:133–147.

5) Rubenstein J and Virasch V. Allergic conjunctivitis. In: Yanoff M and Duker JS, editors. Ophthalmology, 3rd edn.: Mosby Elsevier; 2009. p. 237-40.

6) Ang M, Ti S, Loh R, Farzavandi S, Zhang R, Tan D et al. Steroid-induced ocular hypertension in Asian children with severe vernal keratoconjunctivitis. Clinical Ophthalmology. 2012; 6:1253-58.

7) Rothman JS, Raizman M and Friedlaender MH. Seasonal and perennial allergic conjunctivitis. In: Krachmer JH, Mannis MJ and Holland EJ, editors. Cornea - volume 1 - Fundamentals, diagnosis and management, 2nd edn.: Mosby Elsevier; 2005. p. 661-65.

8) Kumar S, Guptha N and Vivian AJ. Modern approach to managing venal keratoconjunctivitis. Current Allergy and Asthma Reports. 2010; 10(3): 155-62.

9) Bielory BP, Perez VL and Bielory L. Treatment of seasonal allergic conjunctivitis with ophthalmic corticosteroids: in search of the perfect ocular corticosteroids in the treatment of allergic conjunctivitis. Curr Opin Allergy Clin Immunol. 2010; 10(5); 469-77.

10) Heller F. Genetics/genomics and drug effects. Acta Clin Belg. 2013; 68(2): 77-80.

11) Pavesio CE and Decory HH. Treatment of ocular inflammatory conditions with loteprednol etabonate. Br J Ophthalmol. 2008; 92(4):455-59.

12) Bielory BP, O’Brien TP and Bielory L. Management of seasonal allergic conjunctivitis: guide to therapy. Acta Ophthalmol. 2012; 90(5):399-407.

13) Akingbehin AO. Comparative study of the intraocular pressure effects of fluorometholone 0.1% versus dexamethasone 0.1%. Br J Ophthalmol. 1983; 67:661-63.

14) Öner V, Türkcü FM, Tas M, Alakus MF and İşcan Y. Topical loteprednol etabonate 0.5 % for treatment of vernal keratoconjunctivitis: efficacy and safety. Japanese Journal of Ophthalmology. 2012; 56(4):312-18.

15) Ilyas H, Slonim CB, Braswell GR, Favetta JR and Schulman M. Long-term safety of loteprednol etabonate 0.2% in the treatment of seasonal and perennial allergic conjunctivitis. Eye Contact Lens. 2004; 30(1):10-3.

16) Noble S and Goa KL. Loteprednol etabonate: clinical potential in the management of ocular inflammation. BioDrugs. 1998; 10(4):329-39.

9. SIGNATURE OF THE CANDIDATE:

10. REMARKS OF THE GUIDE :

11. NAME AND DESIGNATION OF

11.1 GUIDE : Dr. D.N.PRAKASH., MS

ASSISTANT PROFESSOR,

DEPARTMENT OF OPHTHALMOLOGY,

MYSORE MEDICAL COLLEGE

AND RESEARCH INSTITUTE,

MYSORE

11.2 SIGNATURE :

11.3 CO-GUIDE (IF ANY) :

11.4 SIGNATURE :

11.5 HEAD OF THE DEPARTMENT : Dr. H.T.VENKATE GOWDA M.S. D.O.M.S.

PROFESSOR AND HEAD,

DEPARTMENT OF OPHTHALMOLOGY,

MYSORE MEDICAL COLLEGE

AND RESEARCH INSTITUTE,

MYSORE

11.6 SIGNATURE :

12.1: REMARKS OF DEAN / DIRECTOR:

12.2: SIGNATURE :

ETHICAL COMMITTEE CLEARANCE

TITLE OF THE DISSERTATION: “A comparative study of the efficacy of topical

loteprednol etabonate 0.5% and fluorometholone 0.1% in the treatment of vernal keratoconjunctivitis”

NAME OF THE CANDIDATE: Dr. AMUDHA.A

SUBJECT : M.S. - OPHTHALMOLOGY

NAME OF THE GUIDE : Dr. D.N.PRAKASH., MS

Assistant professor, departmentt of ophthalmology

MMC&RI, Mysore

APPROVED/ NOT APPROVED :

(If not approved, suggestions)

MEDICAL SUPERINTENDENT MEDICAL SUPERINTENDENT K.R. Hospital , Mysore Cheluvamba Hospital, Mysore

PROFESSOR& HEAD PROFESSOR& HEAD

Dept of Medicine, MMC&RI, Mysore Dept of Surgery, MMC&RI, Mysore

SUPERINTENDENT LAW EXPERT

PKTB Hospital, Mysore

DIRECTOR & DEAN

Mysore Medical College & Research Institute, Mysore

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