Biodegradable Collagen Matrix Implant Versus Mitomycin-C in Trabeculectomy: Five-year Follow-up

Overview

Journal BMC Ophthalmol

Publisher Biomed Central

Specialty Ophthalmology

Date 2016 Mar 7

PMID 26946419

Citations 21

Authors

Salvatore Cillino

Alessandra Casuccio

Francesco Di Pace

Carlo Cagini

Lucia Lee Ferraro

Giovanni Cillino

Affiliations

Soon will be listed here.

Abstract

Background: Clinical studies comparing trabeculectomy augmented with Ologen implant (OLO) versus trabeculectomy plus mitomycin-C (MMC) show contradictory results. To obtain long-term data, we report an extended 5-year follow-up trial evaluating the safety and efficacy of OLO as adjuvant compared to low-dosage MMC in trabeculectomy.

Methods: Forty glaucoma patients (40 eyes) assigned to trabeculectomy with MMC or Ologen.

Primary Outcome: target IOP at ≤21, ≤17 and ≤15 mmHg; complete and qualified success endpoint rates.

Secondary Outcomes: visual acuity (VA), mean deviation (MD), bleb evaluation, according to Moorfields Bleb Grading System (MBGS); spectral domain OCT (SD-OCT) bleb examination; number of glaucoma medications; frequency of postoperative complications.

Results: The mean preoperative IOP was 26.7(±5.2) in MMC and 27.3(±6.0) in OLO eyes. Mean 60-month percentage reduction in IOP was significant in both groups [40.9 (±14.2) and 42.1(±13.3) P = 0.01], with an endpoint value of 15.2 (±3.2) and 15.8 (±2.3) mmHg in MMC and OLO, respectively. Complete success rates at ≤ 21 mmHg target IOP were 65% and 70%, at ≤17 mm Hg 60% and 55%, and at the ≤15 mm Hg target IOP 35% and 45% in MMC and OLO, respectively. The Kaplan-Meier curves did not differ both for complete and qualified success at any target IOP, with no significant endpoint intergroup difference at ≤ 15 mm Hg (log-rank P = 0.595).The intergroup MBGS scores differed due to reduced central and peripheral vascularity in MMC group (P = 0.027; P = 0.041). SD-OCT analysis denied differences in bleb height between MMC vs OLO (140.5 ± 20.3 μ vs 129.2 ± 19.3 μ respectively; P =0.079). Mean antiglaucoma medications were significantly reduced (P < 0.0005) from 2.5 (±0.3) to 1.2 (±0.4) in MMC and from 2.6 (±0.2) to 1.4 (±0.3) in OLO group, with no intergroup differences (P = 0.08). Six (30%) cystic thin avascular blebs without oozing were recorded in the MMC group and 2 (10%) in the OLO group, without intergroup difference (P = 0.235).

Conclusions: Our extended follow-up results confirm that Ologen implant yields efficacy and long-term success rates quite similar to MMC, with at least equivalent safety.

Citing Articles

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Collotta D, Colletta S, Carlucci V, Fruttero C, Fea A, Collino M Pharmaceuticals (Basel). 2023; 16(6).

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Park J, Rittiphairoj T, Wang X, E J, Bicket A Cochrane Database Syst Rev. 2023; 3:CD010472.

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Combined trabeculotomy-trabeculectomy with and without augmentation in primary congenital glaucoma: triple-armed randomized controlled trial.

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Trabeculectomy: Does It Have a Future?.

Rao A, Cruz R Cureus. 2022; 14(8):e27834.

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