Adjuvant Role of Amniotic Membrane Transplantation in Acute Ocular Stevens-Johnson Syndrome: A Randomized Control Trial.

ABSTRACT

PURPOSE: To evaluate the adjuvant role of amniotic membrane transplantation (AMT) in cases of acute ocular Stevens-Johnson syndrome (SJS). DESIGN: Prospective randomized controlled clinical trial. PARTICIPANTS: Twenty-five patients (50 eyes) with acute ocular SJS who presented within 4 weeks of onset of symptoms were recruited. METHODS: The eyes were randomized into 2 groups that underwent either AMT with medical therapy (MT; n = 25) or standard MT alone (n = 25). The patients were evaluated at presentation and during follow-up at 1 week and 1, 3, and 6 months. The parameters evaluated were the best-corrected visual acuity (BCVA), Schirmer test, tear film breakup time (TBUT), conjunctival congestion, corneal haze, vascularization, conjunctivalization, and limbal stem cell involvement. Lid edema, symblepharon, ankyloblepharon, ectropion, entropion, trichiasis, and metaplastic lashes also were analyzed. MAIN OUTCOME MEASURES: Maintenance of BCVA and stable ocular surface. RESULTS: At the end of 6 months, the mean BCVA was significantly better in the AMT group (0.068±0.10 logMAR units) compared with the MT group (0.522±0.52 logMAR units; P = 0.042). The mean TBUT in the AMT and MT groups was 9.92±4.1 and 6.96±4.5 seconds, respectively (P = 0.015). The mean Schirmer test results in the AMT and MT groups were 15.4±6.3 and 8.64±5.4 mm, respectively (P < 0.001). Conjunctival congestion persisted in 44% (11/25) in the MT group compared with 4% (1/25) in the AMT group (P = 0.03) at the end of the 6-month follow-up. No case in the AMT group demonstrated corneal haze, limbal stem cell deficiency, symblepharon, ankyloblepharon, or lid-related complications. Among eyes in the MT group, corneal haze occurred in 44% (11/25; P = 0.001), corneal vascularization and conjunctivalization in 24% (6/25; P = 0.03), symblepharon in 16% (4/25; P = 0.12), ankyloblepharon in 4% (1/25; P = 1.00), ectropion and entropion in 8% (2/25; P = 0.47), and trichiasis and metaplastic lashes in 24% (6/25; P = 0.03) eyes. CONCLUSIONS: Amniotic membrane transplantation is a useful adjunct to conventional MT in maintaining BCVA and a stable ocular surface in cases of acute ocular SJS. Furthermore, the adjunctive use of AMT also helps to prevent intermediate-term ocular cicatricial sequelae.