Rajiv Gandhi University of Health Sciences



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|RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA |

|BANGALORE. |

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|ANNEXURE- II |

|PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION |

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| | |DR.JYOTI.S. KHANDRE |

|1. |Name of the candidate and address |POST GRADUATE STUDENT |

| |(in block letters) |MS OPHTHALMOLOGY |

| | |SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, MANJUSHREE NAGAR, |

| | |SATTUR, DHARWAD- 580009 |

| 2. | | |

| |Name of the Institution | |

| | |SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, |

| | |MANJUSHREE NAGAR, SATTUR, |

| | |DHARWAD- 580009. |

| 3. | | |

| |Course of study and subject | |

| | |MS OPHTHALMOLOGY |

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|4. |Date of admission to the course |16-08-2012 |

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| | |COMPARATIVE STUDY OF PREDNISOLONE ACETATE 1% WITH DIFLUPREDNATE 0.05% IN POST OPERATIVE SMALL |

|5. |Title of the Topic |INCISION CATARACT SURGERY |

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| |BRIEF RESUME OF THE INTENDED WORK: |

|6. |6.1 Need for study: Cataract is the leading cause of blindness worldwide, cataract extraction is |

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| |the treatment of choice. This is the commonest surgery performed. Postoperatively steroid drops are used to reduce the inflammation |

| |and pain. |

| |Commonly used ophthalmic suspension such as prednisolone acetate 1% is a potent steroid used in post cataract surgery to reduce |

| |ocular inflammation and pain, but it has some disadvantages like it comes in suspension form for which it has to be shaken |

| |well before use to mix drug properly. Caking in conjunctiva reduces its bioavailability and even the dosage of 6-8 times per day|

| |can have poor patient compliance.1 |

| |Difluprednate is a new synthetic drug available in the market. It is a difluorinated prednisolone derivative. Difluprednate is more|

| |potent than prednisolone acetate. It reduces inflammation and pain more effectively and corneal penetration is also superior to |

| |prednisolone acetate. Corneal edema in postoperative cataract surgery is less with Difluprednate group(38%) as compared with Prednisolone |

| |acetate group (62%). Statistically visual acuity returns faster with Difluprednate eye drops 4 times per day than with the use of |

| |prednisolone acetate 8 times per day. The best corrected visual acuity is better on the first day itself.2 |

| |I would like to study the action of Difluprednate ophthalmic emulsion 0.05% in small incision cataract study on Indians who has dark coloured|

| |iris, different climatic condition and undergoing small incision cataract surgery as compered to westerns who has light coloured iris, cold |

| |climatic condition and undergoing phacoemulsification for cataract surgery. |

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| |6.2 REVIEW OF LITERATURE: |

| |1. William Stringer, Roy Bryant conducted a study in Module 3 Pharma Services, St. Petersburg ,Florida; Encompass Pharmaceautical Services, |

| |Norcross, Georgia.USA. on Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05%verses branded and generic|

| |prednisolone acetate ophthalmic suspension 1% following three storage conditions(upright, then shaken; upright, not shaken; inverted, not |

| |shaken)were analyzed by high performance liquid chromatography assay and results reported in percentage. Two drops dispensed every four hours four |

| |times daily. Regardless of bottle orientation and shaking, all difluprednate emulsion concentrations were within 15% of declared concentration. |

| |Prednisolone acetate suspension concentrations varied substantially throughout the study. They concluded that drop concentration in emulsion form |

| |is more predictable than suspension form.1 |

| |2. Eric D. Donnenfeld et al conducted a multicenter, randomized double-masked trial study in USA and did comparative study of prednisolone |

| |acetate1% with difluprednate acetate 0.05% in postoperative small incision cataract surgery and did a study on corneal thickness, corneal edema, |

| |uncorrected visual acuity, best corrected visual acuity, and intraocular pressure. They enrolled 52 patients who underwent bilateral |

| |phacoemulsification. The one eye received difluprednate 0.05% and other eye received prednisolone acetate. Before surgery, 7 doses were |

| |administered over 2 hours; 3additional doses were administered after surgery, before discharge. Every 2 hours for the remaining day.1st week 4times|

| |daily, 2nd week twice daily. Corneal pachymetry, visual acuity, and corneal edema were evaluated before surgery and at day 1, 15, and 30 after |

| |surgery. They concluded that difluprednate reduced inflammation, more rapid return of vision and superior at protecting cornea.2 |

| |3. Stephen Smith et al and the Difluprednate ST601-004 study group conducted a study at Eye Associates of Fort Myers, Fort Myers, Florida, USA. |

| |Nevada Eye and Ear, Henderson, Nevada, USA on difluprednate ophthalmic emulsion 0.05% administered two times daily for managing ocular inflammation|

| |and pain following cataract surgery. To evaluate the efficacy and safety of difluprednate ophthalmic emulsion 0.05% verses placebo. They enrolled |

| |121 patients, were randomised 2:1 with 1 drop Difluprednate or placebo administered twice daily for 16 days, followed by a 14 day tapering period. |

| |Dosing started 24 hours before surgery. They assessed inflammation, pain, corneal edema, intraocular pressure. They achieved reduced percentage of|

| |inflammation with difluprednate 0.05% than placebo (74.7%vs 42.5%;p=0.0006), pain(64.6%vs30.0%P=0.0004).Three subjects(3.7%) in difluprednate group|

| |had a clinically significant IOP rise. They concluded difluprednate is well tolerated and provides convenient twice-daily for managing |

| |postoperative ocular inflammation.3 |

| |4. Donnenfeld ED, reviewed Difluprednate for the prevention of ocular inflammation post surgery. A comprehensive study done on recent publications|

| |and additional literature retrieved the relative potency of Difluprednate, potential utility in the posterior segment. They proved strength and |

| |unique formulation of difluprednate, along with its potent efficacy in treating and preventing inflammation.4 |

| |5. A clinical practice done by Karim N J Aamal, David G Callanan on the role of Difluprednate ophthalmic emulsion. This review covered the |

| |biochemistry and pharmacology of difluprednate.It is a synthetic difluorinated prednisolone derivative. Its potency is from fluorination at C6, C9 |

| |positions. Inflammatory activity is augmented by replacing the 17- hydroxyl group with buterate, corneal penetration is enhanced by replacing 21- |

| |hydroxyl group with acetate. Difluprednate is formulated in oil based form, polysorbate80 as surfactant which helps in avoiding blurring of vision |

| |and ocular toxicity. They summarized it as Difluprednate ophthalmic emulsion is potent topical steroid that helps in better bioavailability, rapid |

| |local metabolism and strong efficacy with low incidence of adverse effects.5 |

| |6. Korenfeld M S et al conducted a study on Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain at Comprehencive Eye |

| |Care Ltd 901 east 3rd street Washington, missouri 63090, USA. The purpose of study was to assess the efficacy and safety of Difluprednate |

| |ophthalmic emulsion 0.05% 2 or 4 times per day compared with placebo in reducing postoperative inflammation and pain in ocular surgery. Method was|

| |438 patients were divided into 3 groups,1 st group received Difluprednate 2 times per day, 2nd group received same drug 4 times per day,3rd group |

| |received placebo 2 or 4 times per day. A greater proportion of Difluprednate treated patient had a reduction in inflammation and pain than compared|

| |to placebo group. 3% rise intraocular pressure with Difluprednate (> or =10mmhg &> or =21mmhg from baseline)as compared to 1% rise of intraocular |

| |pressure with placebo group. Thus concluded that Difluprednate given 2 or 4 times per day clears post operative inflammation and reduces pain |

| |rapidly and effectively.6 |

| |6.3 Objectives of study: |

| |1) To compare the efficacy of the two drugs, Difluprednate ophthalmic emulsion0.05% and prednisolone acetate 1% in postoperative small |

| |incision cataract surgery. |

| |2) To study outcome of Difluprednate ophthalmic emulsion 0.05% and prednisolone acetate 1% in postoperative small incision cataract surgery |

| |patients. |

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|7. |MATERIALS AND METHODS: |

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| |7.1 Source of data: |

| |Study subjects: |

| |All patients with cataract undergoing small incision cataract surgery during the period of study in Ophthalmology clinic, SDM College of Medical |

| |sciences and Hospital, Dharwad. |

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| |Inclusion Criteria: |

| |The following will be included in the study. |

| |1) All patients with cataract |

| |2) Age> 40 years |

| |3) Patients agreeing to take part in the study in written, informed consent, undergoing small incision cataract surgery during the study period in |

| |Ophthalmology clinic, |

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| |Exclusion Criteria: |

| |The following will be excluded from the study: |

| |1) Age ................
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