Comparasion of efficacy and safety of Difluprednate 0.05% and Nepafenac 0.1% in reducing macular thickness and volume after cataract surgery
Objective- To evaluate and compare efficacy and safety of topical Difluprednate ophthalmic emulsion 0.05% with Nepafenac ophthalmic suspension 0.1% in patients of uneventful cataract surgery with respect to postoperative macular thickness and volume.
Design- A prospective, single centric, tertiary care centre based, comparative, interventional study from August 2013 to July 2014
Subjects- Total 206 ( Group N=106, Group D=100) patients were followed up who completed their 12 weeks follow up
Methodology- Surgery was performed by phacoemulsification technique by clear corneal incision with foldable PCIOL implantation by a single surgeon having 10 years of surgical experience. Post operative patients were divided into 2 groups. Group N were given topical treatment with Nepafenac ophthalmic suspension 0.1% TID starting 24 hours before surgery and continued post-op 4 weeks. Group D were given Difluprednate ophthalmic emulsion 0.05% QID post surgery for 2 weeks followed by BID for 2 weeks.
Main outcome measures: Postoperative assessment of patients were done on 1st day and on 1st, 8th and12th weeks after the surgery for best corrected visual acuity (BCVA) by logMAR, intraocular pressure by Applanation tonometry and macular thickness and volume by SD-OCT. Statistical test used was sample Unpaired and paired ‘t’ test and statistical analysis was done with SPSS 20.0 ( IBM, USA).
Results- There was increase in the measured mean central subfield thickness( CST) at 8 and 12 weeks as compared to 1 week , in both the study groups (P<0.05). On comparing the volume (in mm3) and average thickness (in µm) at 1 week, it was observed that thickness of group N (266.82±25.06 µm) was statistically higher than that of group D (253.14±22.21µm) (P= 0.03). The comparison of best corrected visual acuity (LogMAR) and the intraocular pressure recordings showed no difference between the patients of two studied groups recorded at 1 week and 8 weeks and 12weeks.
Conclusion- Both Nepafenac ophthalmic suspension 0.1% and Difluprednate ophthalmic emulsion 0.05% are equally effective in controlling macular thickness change after uneventful cataract surgery.