A RANDOMIZED TRIAL COMPARING MITOMYCIN-C AND CONJUNCTIVAL AUTOGRAFT AFTER EXCISION OF PRIMARY PTERYGIUM

PURPOSE: To determine the rate of recurrence and complications after b are sclera excision of primary pterygia followed by low-dose mitomycin C (0.2 mg/ml twice daily for five days), placebo (balanced saline sol ution), or conjunctival autograft. METHODS: We performed a prospective , double-masked clinical trial of 64 patients (60 Hispanic) randomly a ssigned to a treatment group. Twenty-four patients received mitomycin C, 23 conjunctival autograft, and 17 placebo. Recurrence was defined a s fibrovascular tissue over the corneoscleral limbus onto clear cornea in the area of previous pterygium excision. RESULTS: The recurrence r ate after mitomycin C and conjunctival autograft was 38% and 39% of ey es, respectively, after mean follow-up (in recurrence-free patients) o f 12.3 and 13.5 months, respectively. The recurrence rate after placeb o treatment was significantly higher (P = .002), 88%, after mean follo w-up (in recurrence-free patients) of 9.3 months. Increasing age was a ssociated with significantly fewer recurrences (P = .006) after contro lling for pterygium type (atrophic, noninflamed, or inflamed) and trea tment group. The mean time to recurrence varied from 3.7 to 4.8 months ; only 6% of recurrences were noted after the sixth postoperative mont h, Major complications included symblepharon (two), loose autograft (o ne), and pyogenic granuloma (two). No group had significantly more com plications. CONCLUSIONS: Conjunctival autograft and low-dose topical m itomycin C are equally effective as adjunctive treatment after excisio n of primary pterygia in this young, southern California, predominantl y Hispanic population. Both methods have significantly lower rates of recurrence than bare sclera excision alone, and neither is associated with severe complications after one year of followup. Increasing patie nt age is associated with significantly less risk of recurrence.