Amniotic Membrane Transplantation in Acute Severe Ocular Chemical Burns: Randomized Double-Masked Clinical Trial
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 burns.
Methods
Sixty eyes of 60 patients within 7 days of injury were included in a parallel-controlled, double-masked clinical trial. Patients were randomly assigned into two groups; Group 1 (30 eyes) received topical preservative-free lubricating gels and drops, chloramphenicol, betamethasone, homatropine, oral vitamin C, and doxycycline. Group 2 (30 eyes) received AMT to the entire ocular surface in addition to the medical treatment provided in Group 1. 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 defect 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 (95% confidence interval [CI]: 0.4 to 2.6) versus 2.06 ± 0.57 logMAR (95% CI: 1 to 2.9), respectively (P=0.850). Although, Group 1 developed more central corneal neovascularization (22 eyes; 73.3%) compared to Group 2 (16 eyes; 53.3%), it was not statistically significant (P=0.098). Mild symblepharon developed in 11 eyes (36.7%) versus 9 eyes (30.0%), respectively (P=0.584).
Conclusion
Compared 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. There was a trend towards reduced corneal vascularization with AMT.