Randomized Controlled Trial of Topical Mitomycin C for Ocular Surface Squamous Neoplasia: Early Resolution

Presented at: American Academy of Ophthalmology Annual Meeting, October 2004, New Orleans, Louisiana.

Received 15 April 2005; accepted 18 September 2006. published online 22 January 2007.

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.

Queensland Eye Institute and University of Queensland, Brisbane, Australia.

Correspondence to Prof Lawrence Hirst, Queensland Eye Institute, 41 Annerley Road, South Brisbane, Australia 4101.

Manuscript no. 2005-323.

Supported by the Prevent Blindness Foundation, Brisbane, Australia, through Viertels Vision.

PII: S0161-6420(06)01330-3

doi:10.1016/j.ophtha.2006.09.026

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