A Prospective Interventional Study to Evaluate the Efficacy of Nepafenac 0.1% for Prevention of Macular Oedema Associated with Cataract Surgery in Patients with Diabetes

ABSTRACT

Pseudophakic cystoid macular oedema is a significant cause of suboptimal visual acuity post phacoemulsification.Diabetics are at greater risk of developing PCME following cataract surgery. Topical nepafenac ophthalmic suspension 0.1% is used to prevent inflammation postoperatively. We wanted to study the effect of Topical Nepafenac 0.1% eye suspension on macular thickness following phacoemulsification in patients of diabetes mellitus and correlate the final visual acuity and macular thickness.METHODSThis prospective interventional study was conducted between January 2018 and May 2019 in the Department of Ophthalmology, MMIMSR, Mullana, Ambala. 100 patients based on the inclusion and exclusion criteria were included in the study and phacoemulsification was done. They were divided in to two groups of 50 each. Group 1 received topical Nepafenac 0.1% ophthalmic suspension thrice daily along with the routine post-op medications whereas Group 2 received routine post-op medications. The groups were analysed preoperatively and at 2, 4, 6, 8 weeks postoperatively and their CMT was recorded using a SD-OCT. The change in BCVA was analysed with the help of ETDRS letter chart. The data was entered in Microsoft Excel and analysed using SPSS-PC-20 version. Quantitative data was expressed by mean and standard deviation while qualitative data was expressed as percentage. Difference between the proportions was tested with Chi Square Test or Fisher’s Exact test while difference between quantitative variable between the two groups was tested with students ’t’ test or Mann Whitney U test. For comparison of quantitative data between more than two groups, ANOVA or Kruskal Wallis ‘H’ test followed by post hoc test was used. A ‘p’ value of less than 0.05 was considered statistically significant.RESULTSA lower percentage of patients in Group 1 developed ME relative to Group 2 (2% vs. 8%; p-value= 0.36). The mean CMT was significantly lower in Group 1 at 2 (p-value<0.01), 4 (p-value<0.001), 6 (p-value<0.001) and 8 weeks (p-value<0.001). A greater percentage of patients in Group 1 (60%) experienced a gain of >15 letters as compared to the baseline (p-value<0.01)