Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial

Abstract

Aim: To verify the safety and efficacy of Ologen (OLO) implant as adjuvant compared with low-dosage mitomycin-C (MMC) in trabeculectomy.

Methods: This was a prospective randomized clinical trial with a 24-month follow-up. Forty glaucoma patients (40 eyes) were assigned to trabeculectomy with MMC or OLO. Primary outcome includes target IOP at ≤21, ≤17, and ≤15 mm Hg; complete (target IOP without medications), and qualified success (target IOP regardless of medications). Secondary outcomes include bleb evaluation, according to Moorfields Bleb Grading System (MBGS); spectral domain optical coherence tomography (SD-OCT) examination; number of glaucoma medications; and frequency of postoperative adjunctive procedures and complications.

Results: The mean preoperative IOP was 26.5 (±5.2) in MMC and 27.3 (±6.0) in OLO eyes, without statistical significance. One-day postoperatively, the IOP dropped to 5.2 (±3.5) and 9.2 (±5.5) mm Hg, respectively (P=0.009). The IOP reduction was significant at end point in all groups (P=0.01), with a mean IOP of 16.0 (±2.9) and 16.5 (±2.1) mm Hg in MMC and OLO, respectively. The rates and Kaplan-Meier curves did not differ for both complete and qualified success at any target IOP. The bleb height in OLO group was higher than MMC one (P<0.05). SD-OCT analysis of successful/unsuccessful bleb in patients with or without complete success at IOP ≤17 mm Hg indicated a sensitivity of 83% and 73% and a specificity of 75% and 67%, respectively, for MMC and OLO groups. No adverse reaction to OLO was noted.

Conclusions: Our results suggest that OLO implant could be a new, safe, and effective alternative to MMC, with similar long-term success rate.

Figure 1

Box-plot representation of IOP values over 24 months of follow-up: median values (dark lines), error standard (T-bars), and outliers (circles).

Figure 2

Kaplan–Meier cumulative probability curve of complete success (without medications) at ≤15 mm Hg target IOP in MMC (solid line) vs OLO group (dotted line) (log-rank test P=0.349).

Figure 3

SD-OCT imaging of blebs postoperatively in eyes with or without complete success based on ≤17 mm Hg target IOP. Successful (‘thickened') blebs in eye with complete success (MMC adjuvant, top left; OLO adjuvant, top right). Failed (‘non-thickened') blebs without complete success (MMC adjuvant, bottom left; OLO adjuvant, bottom right).