Five RCTs (416 participants) were included. Mean follow-up time was 10.4 months. Three RCTs reported adequate sequence generation and allocation concealment. Blinding was reported in four RCTs and incomplete outcome data were adequately addressed in one RCT. No RCTs addressed selective outcome reporting. One RCT was reported to have other (undefined) sources of bias.
Adjuvant mitomycin C was associated with a statistically significantly lower mean intraocular pressure level following trabeculectomy than with 5-FU (MD -2.17mmHg, 95% CI -3.26 to -1.08; four RCTs). There were no significant differences between groups for the final number of glaucoma medications (two RCTs).
Qualified surgical success rates were higher for treatment with mitomycin C compared with 5-FU when intraocular pressure was up to 21mmHg (OR 2.19, 95% CI 1.18 to 4.08; five RCTs) and intraocular pressure up to 18mmHg (OR 1.82, 95% CI 1.01 to 3.28; three RCTs).
Complete success rates were also higher for treatment with mitomycin C compared to 5-FU with an intraocular pressure of up to 21mmHg (OR 1.67, 95% CI 1.04 to 2.69; four RCTs).
In subgroup analyses high dose mitomycin C was significantly associated with a higher rate of qualified success (intraocular pressure ≤21mmHg) than 5-FU; a higher proportion of eyes treated with mitomycin C achieved qualified success compared with those treated with intraoperative 5-FU. Other subgroup analyses did not report any statistically significant differences between groups.
There was a significantly lower incidence of postoperative corneal epithelial defects for mitomycin C compared to 5-FU (OR 0.25, 95% CI 0.08 to 0.79; three RCTs). There were no statistically significant differences for other adverse events.
Statistical heterogeneity, where reported, appeared to be low to moderate (Ι²=0% to Ι²=56%).