Phacotrabeculectomy using collagen matrix implant (Ologen^®) versus mitomycin C: a prospective randomized controlled trial

Abstract

Purpose: To compare the efficacy and safety of collagen matrix implant (Ologen â ; OLO) with mitomycin C (MMC) in phacotrabeculectomy. Methods: Prospective, single-centre, nonblinded, randomized controlled trial. A total of 53 eyes of 45 patients were enrolled in the study protocol with 27 eyes randomly assigned to OLO and 26 to MMC. The follow-up was 12 months. The primary outcome measure was mean change from baseline intraocular pressure (IOP) in both groups after 12 months. The secondary outcome measures were cumulative success rates at 12 months with Kaplan-Meier analysis, change in number of medications, change in best corrected visual acuity (BCVA), and bleb morphology assessed using Moorfields Bleb Grading System and anterior segment swept-source optical coherence tomography. Results: The mean IOP decreased from 26.4 AE 6.1 mmHg to 13.7 AE 3.8 in the OLO group and from 23.4 AE 3.6 mmHg to 13.3 AE 2.8 in the MMC group at 1 year without significant intergroup differences. At 1 year, the overall success rates were 92.6% and 92.3% in the OLO and MMC groups, respectively. There were no significant differences in the overall success rates, BCVA, number of medications, morphology of the filtering blebs and rate of complications at the end of the follow-up. Conclusion: Ologen (OLO) provides similar surgical outcomes in phacotrabeculectomy compared with adjunctive MMC. It may be a new, safe and effective alternative to MMC for combined phacoemulsification and trabeculectomy surgery.

Commentary: Implantable collagen devices in optimizing filtering success - The holy grail?

“…The authors observed that bleb morphology, mean IOP, and medications at 1 year were comparable in the two groups. This is largely in agreement with the earlier studies[ 5 6 7 8 ] comparing collagen matrix and Mitomycin in phacotrabeculectomy published in other populations. In a prospective randomized control trial of phacotrabeculectomy using Collagen matrix or Mitomycin, Wlaz et al .…”

“…In a prospective randomized control trial of phacotrabeculectomy using Collagen matrix or Mitomycin, Wlaz et al . [ 7 ] had observed that the former provides similar surgical outcomes compared with Mitomycin and concluded it to be safe and effective alternative to Mitomycin for combined phacotrabeculectomy surgery. These results were in predominantly Caucasian eyes and may not necessarily be applicable across all ethnic groups.…”

“…Whereas Collagen matrix has been observed to cause comparable IOP control with reduction in hypotony-related adverse effects in a Caucasian population, similar efficacy has not been seen in Asian and Indian eyes, although long-term hypotony in general has been significantly lesser in eyes which have had adjunctive collagen implants as opposed to those treated with Mitomycin. [ 4 6 7 8 ] In lesser developed economies such as India and elsewhere, it is crucial to balance cost effectiveness with benefits from interventions to lower IOP and prevent progressive glaucoma. Collagen implants used in glaucoma filtering surgery are expensive and may not be as effective as Mitomycin[ 5 ] in preventing subconjunctival bleb fibrosis and prolong bleb function to achieve lower-target pressures.…”

Comparison of bleb morphology by anterior segment optical coherence tomography and clinical outcome after phacotrabeculectomy with mitomycin C or Ologen implant

“…We found equal control of IOP at all time points with no inter group difference at 12 months which was similar to the results by Wlaz et al . [ 21 ] In contrast, Narayanaswamy et al . [ 22 ] found a greater percentage reduction of IOP in MMC group than in Ologen group at one year; however, IOP decrease at one year was not statistically different in the two groups, while Boey et al .…”

“…There was no intergroup difference in the mean number of medications at end point in our study, which was similar to that found by other authors. [ 13 21 ]…”