RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



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|RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES |

|KARNATAKA, BANGALORE |

|ANNEXURE II |

|PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION |

|1. |NAME OF THE CANDIDATE & ADDRESS |DR. TALPALLIKAR NEHA |

| | |Post graduate student MS |

| | |Ophthalmology Sri |

| | |Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, |

| | |Manjushree Nagar, Sattur, Dharwad - 580009 |

| |NAME OF THE INSTITUTION |Sri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, |

|2. | |Manjushree Nagar, Sattur, Dharwad - 580009 |

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|3. |COURSE OF STUDY AND SUBJECT |MS Ophthalmology |

|4. |DATE OF ADMISSION TO THE COURSE |31-05- 2011 |

|5. |TITLE OF DISSERTATION |COMPARATIVE STUDY OF EFFICACY OF TOPICAL BROMFENAC SODIUM 0.09% AGAINST TOPICAL |

| | |PREDNISOLONE ACETATE 1% IN POSTOPERATIVE CATARACT PATIENTS |

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|6. |BRIEF RESUME OF THE INTENDED WORK: |

| |6.1 Need for study: |

| |Cataract is the leading cause of blindness worldwide and cataract extraction is |

| |the treatment of choice leading to improvement in quality of life, cognitive function and |

| |productivity as reported by multiple published studies.1 To maximize the outcome of |

| |cataract surgery, post-operative treatment includes antimicrobials, NSAIDs and a potent |

| |steroid.1 Studies have shown the benefit of antimicrobials in prophylaxis against ocular |

| |infection and endophthalmitis, NSAIDs for reducing macular edema and steroids for |

| |reducing anterior chamber reaction.1 From the perspective of the adverse effects of |

| |steroids like delayed wound healing, increase in intraocular pressure and increase in |

| |chances of infection due to non specific immunosuppressive action, the postoperative |

| |use of steroids is best avoided.2 |

| |The advent of topical NSAIDs provides the ocular surgeon with alternative |

| |approach to the control of postoperative inflammation that may have distinct advantages |

| |over the corticosteroid use. Topical NSAIDs are of multifunctional therapeutics. They |

| |were first used in cataract surgeries for the prevention of surgically induced miosis, but |

| |now they have been shown to be effective in controlling pain of the surgery and to have |

| |the potential in treating and preventing cystoid macular edema. The NSAID, Bromfenac |

| |has shown to reduce the surgically induced miosis, ocular inflammation and CME.3 |

| |The recent advances in the cataract surgeries like phacoemulsification and the |

| |use of foldable IOLs, the chances of postoperative ocular inflammation are reduced.2 |

| |Chances of high grade fibrinous reaction is low.2 So, the use of potent steroids can be |

| |avoided and instead Non Steroidal Anti Inflammatory Drugs can alone be used in |

| |combating the ocular inflammation. So a study is needed for the substitution of potent |

| |steroids with Non Steroidal Anti Inflammatory Drug like Bromfenac sodium. Hence in |

| |the present study, the effects of bromfenac sodium will be studied and compared with |

| |that of prednisolone acetate in postoperative cataract patients. |

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| |6.2 REVIEW OF LITERATURE: |

| |1. Duong HQ, Westfield KC, Singleton IC studied taking 137 patients at Las Vegas, |

| |USA, the comparison of Intraocular Pressure, degree of post operative anterior |

| |chamber inflammation and macular edema among three different groups with different |

| |treatments in a prospective, randomized, single blind study. Preoperative evaluation |

| |included a comprehensive ophthalmic examination and baseline macular optical |

| |coherence tomography (OCT). The control group was given gatifloxacin 0.3%, |

| |prednisolone acetate 1% and bromfenac 0.09%. The second group was given |

| |gatifloxacin 0.3% and bromfenac 0.09%.The third group was given one intraoperative |

| |steroid (triamcinolone) injection, gatifloxacin and bromfenac in the postoperative |

| |period. Postoperative data included intraocular pressure and anterior chamber cell |

| |count at 1 day, 1 week and 1 month postoperatively. Macular OCTs were performed at |

| |1 week and 1 month postoperative. This study concluded that all the three regimens |

| |were equally efficient in decreasing the IOP and preventing the cystoid macular edema |

| |(foveal thickness was used to determine the degree of macular inflammation). The study |

| |was statistically insignificant with p=0.39 for anterior chamber inflammation and |

| |p=0.82 for foveal thickness .The IOP were high on 1st postoperative day but were |

| |statistically insignificant (p=0.15). The IOPs reached normal level by one week.1 |

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| |2. Nishino M, Eguchi H, Iwata A, Shiota H, Tanaka M, Tanaka T in Japan, conducted a |

| |single blind, randomized and prospective study in 21 patients, with 11 patients assigned |

| |to steroid group and 10 to non steroid group. After phacoemulsification with posterior |

| |chamber IOL, they were given the respective drugs that were assigned to them. Visual |

| |acuity, anterior chamber flare and cells and corneal endothelial cell density were |

| |examined. After 1 month postoperatively, no difference was observed between the two |

| |groups in terms of the outcomes described earlier. No evidence of CME was detected. |

| |This study concluded that, topical steroid medication may not be absolutely essential |

| |after an uneventful Phacoemulsification with posterior chamber IOL.2 |

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| |3. Donnenfeld ED, Holland EJ, Stewart RH, Gow JA, Grillone LR conducted a |

| |multicenter, randomized, double masked, parallel, placebo controlled clinical trial to |

| |evaluate the efficacy and ocular safety of Bromfenac ophthalmic solution 0.09% for the |

| |treatment of postoperative inflammation and reduction of ocular pain in subjects who |

| |underwent cataract extraction. 527 subjects were assigned sequentially according to a |

| |computer generated randomized list in 2:1 ratio i.e. 2 bromfenac to 1 placebo ratio. The |

| |subjects without any prior anti inflammatory treatment with postoperative Summed |

| |Ocular Inflammation Score(SOIS) of 3 or more than 3 were treated with either |

| |Bromfenac or the placebo instilled twice daily for 14 days. They were observed on 15th |

| |day. The baseline mean SOIS was 3.7 in both groups. A greater proportion of bromfenac |

| |(64%) than placebo subjects (43.3%) achieved complete clearance of ocular |

| |inflammation on 15th day (p ................
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