To compare the effectiveness and safety of degradable collagen matrix implant (Ologen) with mitomycin C in trabeculectomy

In a prospective randomized clinical trial 40 patients with uncontrolled glaucoma assigned to trabeculectomy with MMC or Ologen. All patients had comprehensive ophthalmologic examination. Main outcome measure was IOP and secondary outcome measures were VA, number of anti-glaucoma medications, bleb morphology and complications. Success defined as complete if the intraocular pressure was > 5 and ≤ 15 mm Hg without anti-glaucoma medications and qualified if an IOP was > 5 and ≤ 15mm Hg with anti-glaucoma medications. All patients had at least 6 months follow up.

The mean intraocular pressure was 18.85 ± 4.9 mmHg in MMC and 22.16 ± 6.31 mmHg in Ologen group which decreased to 9.5 ± 4.9 mmHg (P=0.000) and 14.1 ± 5.9 mmHg at month 6 respectively (P=0.003). Mean intraocular pressure was significantly lower at day 1 and 7 in the Ologen group as compared to MMC group (P=0.007, P=0.001 respectively) but at 6 months it was significantly lower in the MMC group (P=0.013). Number of antiglaucoma medications was 3.4±0.6 in MMC group and 3.5±0.51 in Ologen group which decreased significantly to 0.15±0.49 and 0.3±0.61 respectively (P=0.000). Complete success rate was 90% for MMC group and 61.1% for Ologen group (P=0.047). Patients in MMC group had significantly more extensive bleb in compared with Ologen group. (P=0.005). Early hypotonia was significantly higher in Ologen group (P=0.037) but late hypotonia was more in MMC group (5 cases versus 1 case). It was not statistically significant but had clinical significance.

The success rate of trabeculectomy with MMC was higher than trabeculectomy with Ologen in reaching to low target intraocular pressure. Trabeculectomy with mitomycin induced more extensive blebs, but complications such as late hypotonia occurred more in these patients.patients.