EFFECTIVENESS AND SAFETY OF AMNIOTIC MEMBRANE GRAFTING FOR CORNEAL SURFACE DISORDER: A RANDOMIZED CLINICAL STUDY

Abstract

Objective: The aim of the study was to evaluate the effectiveness and safety of freeze-dried amniotic membrane grafting (AMG) and compare it against traditional medical therapy for the management of corneal surface disorders. Methods: A randomized clinical trial was conducted on 60 patients with corneal surface disorders who were randomized equally either into the AMG group (n=30) or medical management group (n=30). Patients in both groups were followed up for 8 weeks after receiving group-specified intervention or till complete resolution (whichever was earlier). Treatment outcome, healing time, improved vision, decreased pain, recurrence rate, and corneal clarity were the main outcome metrics. Results: The most common corneal disorder was persistent epithelial defect (38.33%), closely followed by impending perforated corneal ulcer (31.66%). Majority of the patients (36.66%) had corneal involvement of >75%, while 31.66% had involvement ranging from 50 to 75%. The success rate of AMG (96.7%) was significantly higher than that of medical management (76.7%) in the treatment of corneal surface disorders (p=0.022). During the follow-up period, the incidence of allergic reactions was slightly lower in the AMG group (6.7%) compared to the medical management group (10.0%). Overall, the incidence of side effects and other complications was low in both the AMG group and the medical management group. The severity of side effects was comparable in both the study groups (p=0.886). The recurrence rate of corneal surface disorders in the in the AMG group (6.7%) was statistically lower than that in the medical management group (26.7%) (p=0.037). Conclusion: The findings of the present study supported the use of AMG as an effective and safe alternative to medical management for the treatment of conditions affecting the corneal surface.