Abstract
BackgroundClinical 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.MethodsForty 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.ResultsThe 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).ConclusionsOur extended follow-up results confirm that Ologen implant yields efficacy and long-term success rates quite similar to MMC, with at least equivalent safety.Electronic supplementary materialThe online version of this article (doi:10.1186/s12886-016-0198-0) contains supplementary material, which is available to authorized users.
Highlights
Clinical studies comparing trabeculectomy augmented with Ologen implant (OLO) versus trabeculectomy plus mitomycin-C (MMC) show contradictory results
To obtain more data on the long-term intraocular pressure (IOP) lowering effect of the Ologen implant compared to MMC as adjuvant in trabeculectomy, we extended to five years the follow-up on the same cohort of subjects of our abovesaid study
Hospital of Palermo (Italy) on December 2007 and registered under the number 08/07 (12 September 2007) .We reviewed the records of 40 patients who had been randomly assigned to undergo a trabeculectomy with MMC (MMC group) or a trabeculectomy with Ologen implant (OLO group) for primary open-angle (POAG) or pseudoexfoliative glaucoma (PEXG) at the Department of Ophthalmology of the University of Palermo
Summary
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. A biodegradable collagen-glycosaminoglycan copolymer matrix implant (Ologen®) has been proposed as an alternative adjuvant, used as a spacer to mechanically separate the sub conjunctival and episcleral tissues to preventing fibrosis, and helps in reorganizing the subconjunctival scar formation. In the same year another randomized study of MMC-augmented trabeculectomy vs trabeculectomy using Ologen showed a lower complete success rate but a lower bleb-associated complication rate in Ologen group [11]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have