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Published on: February 15, 2022
The Effect of a Novel Strategy in Treating Primary Pterygium: A Prospective Randomized Clinical Study
1Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology and Visual Science Key Lab, Beijing, China.
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.
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