A One Year Randomised Clinical Trail To Compare The Efficacy And Safety Of Topical Difluprednate Ophthalmic Emulsion 0.05% With Topical Prednisolone Acetate 1% Ophthalmic Suspension In The Control Of Post-Operative Inflammation Following Cataract Surgery In Kles Dr.Prabhakar Kore Hospital Belgaum

Abstract

BACKGROUND: Cataract is responsible for 50% of blindness in the world; the overall prevalence rate varies from 1% to 4% of the population and it should be performed with equal emphasis on quality and quantity of surgery. Cataract surgery is the most common ophthalmic surgery performed. A mild postoperative inflammation may be considered a normal accompaniment of cataract surgery rather than its complication Surgical techniques in all fields of ophthalmology has evolved considerably over the years from transition to clear corneal incisions by anterior segment surgeons to adoption of small-gauge minimally invasive pars plana vitrectomies by vitreo-retinal specialists Just as ophthalmologists have enjoyed advances in surgical technique and technology, patient expectations of their results have grown proportionately. Currently, the most widely prescribed strong topical corticosteroid in India is prednisolone acetate1%.While, it controls inflammation effectively, it has not been shown to consistently address post-operative pain and discomfort in a large clinical trail. Thus, Difluprednate is the first ophthalmic steroid developed in the past 35 years iv with high potency, a favorable safety profile, and the ability to reduce postoperative pain. OBJECTIVES: 1. To study the efficacy and safety of topical Difluprednate 0.05% ophthalmic emulsion with topical Prednisolone Acetate 1% ophthalmic suspension in control of post-operative inflammation following cataract surgery. 2. Measurement of IOP in study population. METHODOLOGY: A total of hundred patients diagnosed senile cataracts coming to KLES Dr. Phabhakar Kore Hospital Belgaum over a one year period who fulfilled the inclusion criteria were enrolled in the study. The patients were divided into two groups. The post-operative grades of inflammation following cataract surgery was assessed by slit-lamp examination. t test. Statistical analysis was done using Student’s ‘t’ test, chi square test and paired RESULTS: In the present study, the average age group of patients in Difluprednate group was 60.5 years while in Prednisolone group was 58.8 years. Maximum of the total patients were in age group of 60 to 69 years, male: female ratio in Dfluprednate group was 29:21 and in Prednisolone group was 35:15. Majority of the cases were senile immature cortical cataract ( 50% ) out of which 22 patients ( 44% ) were in Difluprednate group and 25 patients ( 50% ) in Prednisolone group. Maximum number of patients were in the range of 14.6 to 15.9 mmHg in terms of IOP. In the present study, only12% in Difluprednate group and 12% patients in Prednisolone group had lid edema on Day 1. By Day 7 the lid edema subsided in both v the groups. Conjunctival congestion persisted in 6% patients in Prednisolone group as compared with none of the patients in Difluprednate group on day 15.Ciliary congestion was seen in 3% patients in the Prednisolone group as compared with none of the patients in Difluprednate group by Day 15. Corneal edema was reduced equally by both the drugs at all observation times. Anterior chamber flare and cells –Mild flare was seen in 22% of patients in Prednisolone group and in only 8% of patients in the Difluprednate group by day 15, which regressed completely in both the groups by day 30. When the total scoring of all these parameters was compared, in Prednisolone group 34% of the patients persisted with mild ( Grade1-3) inflammation on Day 15 as compared with 26% of the patients in Difluprednate group. CONCLUSION: From, the present study it was noted that both Difluprednate Ophthalmic Emulsion 0.05% eye drops and Prednisolone Acetate.1% eye drops were equally effective in reducing the inflammation following uncomplicated cataract surgery. With proven efficacy of Difluprednate, we now have a new standard for potency in a topical corticosteroid, with excellent anti-inflammatory properties and an ideal formulation for our patients