Lekha Abraham, Andrew Braganza, Arathi Simha, Smita Dikshit, Femi Sam

Purpose: To compare the long term efficacy and safety of intra-operative sub-conjunctival collagen matrix implantation (Ologen®) versus Mitomycin-C (MMC) in phacotrabeculectomy.
Method: 63 patients, randomized to undergo phaco- trabeculectomy with sub-conjunctival Ologen® implantation or MMC in 2011, were followed up for 5 years. The primary objectives were to compare intra- ocular pressure (IOP) and bleb morphology between the two groups using clinical photographs by Moor- field’s Bleb Grading System (MBGS) and anterior segment optical coherence tomography (ASOCT). Target IOP was defined preoperatively. Sample size calculated to show 0.26 μm difference in bleb height with 80% power and 5% significance was 28.
Results: Of the 35 patients achieving follow up for 5 years, 30 (16 Ologen®, 14 MMC) achieved target IOP. There was no significant difference in IOP reduction between the two groups (P = 0.815). Using MBGS, bleb height was 1.533 0.516 in the Ologen® group and 1.571 0.646 in the MMC group (P = 0.862). Central bleb area was 1.60
0.507 and 1.571 0.513 respectively (P = 0.881). Bleb vascularity was 1.866 0.516 in the Ologen® group and 1.714 0.468 in the MMC group (P = 0.414). The total bleb height in μm using ASOCT was 991.88 179.66 and 986.43 270.12 respec- tively (P = 0.946). The conjunctival thickness was also similar in both the groups (P = 0.318). No patients had blebitis or bleb sweat. However, 3 patients in the MMC group had thin-walled, poly- cystic blebs.
Conclusions: Ologen® is as effective and safe as
MMC in long term success of phacotrabeculectomy. The bleb morphology using MBGS and ASOCT were similar in the long term.