Purpose. To evaluate the potential benefit of adjunctive mitomycin C in patients with primary open angle glaucoma, primary angle closure glaucoma, pigmentary or pseudoexfoliative glaucoma, undergoing primary trabeculectomy combined with phacoemulsification and intraocular lens implantation. Methods. 30 eyes of 30 patients were randomized in this prospective, multi-center, double-masked clinical study to receive either mitomycin C (0.4 mg./ml.) or placebo during the combined triple procedure. The difference and relative difference of intraocular pressure (IOP) and visual acuity (VA) were measured preoperatively and at 1,3,6, and 12 months. To check for any biases in the randomization process or clinic, a two-sample t-test was used to test for drug or clinic differences in the mean preoperation measures. An analysis of variance (ANOVA) model was used to calculate the difference and relative difference in the measures using drug and clinic as factors. A p-value < 0.05 was deemed statistically significant for all tests. Results. Results of the two-sample t-test on age, IOP and VA showed no significant difference between the drug groups or the clinic sites. Results of the ANOVA showed that there was no drug effect at any of the visits in any of the measures, including IOP. Conclusions. The use of mitomycin C did not produce any significant reductions in the IOP as compared to the placebo in this study.
|Original language||English (US)|
|Journal||Investigative Ophthalmology and Visual Science|
|State||Published - Feb 15 1996|
ASJC Scopus subject areas
- Sensory Systems
- Cellular and Molecular Neuroscience