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

Objective 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. Design Randomized controlled clinical trial. Methods 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 12 months. Primary outcomes included recurrence rate and complications. Secondary outcomes included corneal epithelium status, ocular surface symptom score, and visual acuity change. Results 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. Conclusions 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. 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 12 months. 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.