The Effect of a Novel Strategy in Treating Primary Pterygium: A Prospective Randomized Clinical Study

Abstract

We sought to compare the efficacy and safety of conjunctival autograft (CAG), amniotic membrane transplantation (AMT) with postoperative interferon alfa-2b (IFN alfa-2b), and modified conjunctival autograft plus amniotic membrane transplantation (mCAG plus AMT) with postoperative IFN alfa-2b for primary pterygium. Randomized controlled clinical trial. Eyes with nasal and primary pterygia were randomized in a 1:1:1 ratio to receive CAG, AMT with IFN alfa-2b, or mCAG plus AMT with IFN alfa-2b. Subjects were followed up for 12months. Primary outcomes included recurrence rate and complications. Secondary outcomes included corneal epithelium status, ocular surface symptom score, and visual acuity change. Eighty-five subjects (30 in the CAG group, 25 in the AMT group, and 30 in the CAG+AMT group) completed the 12-month follow-up. No complication or grade 4 recurrence was found. There was no significant difference among the 3 groups in recurrence grade, corneal epithelium status, and visual acuity change. Compared with mCAG+AMT, CAG has a negative effect (β=-0.62, P= .001), and AMT has a negative effect (β=-2.02, P < .001) on postoperative symptom scores. Compared with AMT, CAG has a positive effect (β= 1.28, P < .001) on postoperative symptom scores. All 3 strategies had good safety and clinical efficacy in the study. Compared with conjunctival autograft, the 2 surgeries using no autograft or limited autograft was less traumatic and gave more flexibility for future ocular surface condition changes.