Randomized controlled trial of topical mitomycin C for ocular surface squamous
neoplasia: early resolution.
Author(s): Hirst LW(1).
Affiliation(s): Author information:
(1)Queensland Eye Institute and University of Queensland, Brisbane, Australia.
lawrie.hirst@pbf.org.au
Publication date & source: 2007, Ophthalmology. , 114(5):976-82
OBJECTIVE: To assess the efficacy and safety of mitomycin C in the treatment of
ocular surface squamous neoplasia.
DESIGN: Prospective, randomized, controlled, masked, single-center trial.
PARTICIPANTS: Forty-eight consecutive patients with biopsy-proven noninvasive
ocular surface squamous neoplasia.
INTERVENTION: Mitomycin C (0.4 mg/ml) or a placebo was administered as 1 drop 4
times a day for 3 weeks, with crossover of drops if there was no regression
within 6 weeks.
MAIN OUTCOME MEASURES: Successful treatment was measured as complete resolution
of the neoplasia by slit-lamp examination within 6 to 8 weeks of treatment, with
a secondary end point of histological resolution by 6 weeks.
RESULTS: None of 20 in the placebo group resolved clinically, whereas 24 of 26 in
the mitomycin group resolved, giving a relative resolution rate of mitomycin
versus placebo of 40.87 (95% confidence interval [CI], 1.01-1656.8). There were
no complications. There was no statistical treatment effect on histological
resolution, with a resolution rate of mitomycin versus placebo of 1.37 (95% CI,
0.34-5.42).
CONCLUSIONS: Mitomycin C (0.4 mg/ml) eyedrops used 4 times a day for 3 weeks is
an effective agent to cause early clinical resolution of noninvasive ocular
surface squamous neoplasia.
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