Prospective Randomized Trial Comparing Mitomycin C Combined with Ologen Implant versus Mitomycin C Alone as Adjuvants in Trabeculectomy.

PURPOSE: Comparative evaluation of trabeculectomy with mitomycin C (MMC) versus trabeculectomy with MMC plus Ologen (Aeon Astron Europe, Leiden, The Netherlands).

DESIGN

Prospective, randomized, comparative study.

PARTICIPANTS

Fifty eyes of 50 patients with primary open-angle glaucoma or pseudophakic primary angle-closure glaucoma were recruited.

METHODS

Twenty-five eyes underwent trabeculectomy with low-dose MMC alone (0.1 mg/ml for 1 minute; MMC group) and 25 eyes underwent trabeculectomy with low-dose MMC plus Ologen (Ologen group) at a tertiary eye care center. Only patients with minimum follow-up of 12 months were included in the study.

MAIN OUTCOME MEASURES: Percentage reduction in intraocular pressure (IOP). Secondary outcome measures included percentage of patients achieving absolute and qualified success for IOP of less than 15 mmHg and less than 18 mmHg, bleb morphological features, need for antiglaucoma medications, and rate of complications.

RESULTS

The mean preoperative IOP was 25.96±4.82 mmHg and 26.32±4.27 mmHg in the MMC and Ologen groups, respectively (P = 0.81). Mean postoperative IOP at 12 months was 11.33±3.18 mmHg in the MMC group and 14.35±3.34 mmHg in the Ologen group (P < 0.001 at all visits in both the groups). Significantly higher IOP reduction was noted in the MMC group at both 6 months (56.9% vs. 47.1%; P = 0.035) and 12 months (55% vs. 44.2%; P = 0.019). Cumulative success (absolute plus qualified success) was achieved in 86.3% of eyes in the MMC group compared with 73.9% of eyes in the Ologen group (P = 0.46) when IOP of 15 mmHg or less was considered as the definition of success.

CONCLUSIONS

The addition of a biodegradable collagen implant (Ologen) does not improve efficacy of MMC-augmented trabeculectomy in primary adult glaucomas.