Amniotic Membrane Transplantation in Acute Severe Ocular Chemical Injury: A Randomized Clinical Trial.

Abstract

Abstract Purpose To compare the outcomes of conventional medical treatment versus combined medical treatment and amniotic membrane transplantation (AMT) in the management of patients with Roper-Hall grade IV ocular chemical injury. Design Randomized, parallel-controlled clinical trial Methods Setting: Single tertiary referral hospital. Patients: 60 eyes of 60 patients with Roper-Hall grade IV ocular chemical injury with a minimum follow-up of 12 months were enrolled in the study. Intervention: Patients were randomly assigned to two groups; Group 1 (30 eyes) received topical preservative-free lubricating gel and drops, chloramphenicol, betamethasone, homatropine, oral vitamin C, and doxycycline. Group 2 (30 eyes) received amniotic membrane transplant (AMT) on the entire ocular surface in addition to the medical treatment provided in Group 1. Main Outcome Measures : The main outcome measure was time to complete corneal epithelialization. Secondary outcome measures were best-corrected visual acuity (BCVA) and neovascularization in the central 5 mm of the cornea. Results Mean follow-up time was 20.3 ± 2.5 months (13-24 months). Corneal epithelial defects healed within 72.6 ± 30.4 days (21 to 180) in Group 1 versus 75.8 ± 29.8 days (46 to 170) in Group 2 ( P =0.610). Mean BCVA was 2.06 ± 0.67 logMAR (0.4 to 2.6) versus 2.06 ± 0.57 logMAR (1 to 2.9) in Groups 1 and 2, respectively ( P =0.85). Group 1 developed more central corneal neovascularization (22 eyes; 73.3%) compared to Group 2 (16 eyes; 53.3%), however, it was not statistically significant ( P =0.108). Conclusions In comparison to conventional medical therapy, combined amniotic membrane transplantation and medical therapy does not accelerate corneal epithelialization or affect final visual acuity in severe chemical injuries.