Aims: To compare the long-term effects of low-dosage mitomycin C (MMC) in both deep sclerectomy (DSMMC) and trabeculectomy (TPMMC) on intraocular pressure (IOP). Methods: Analysis of extended follow-up of data from a prospective clinical trial. Forty patients were originally randomised to undergo either DSMMC (19 eyes) or TPMMC (21 eyes). Follow-up was performed at postoperative day 1, weeks 1, 2 and 3, as well as months 1, 3, 6, 9, 12, 18, 24, 36 and 48. Two- to three-week data were not included in the statistical analysis. Postoperative complications, number of antiglaucoma medications and IOP were recorded at each visit. Complete (no medications) and qualified (with or without medications) successes were assessed at 2 target IOPs (≤21 and ≤17 mm Hg) and evaluated by Kaplan-Meier curves. Results: At 48 months, the mean IOP (± SD) was 17.6 ± 3.4 and 17.8 ± 3.6 mm Hg in the DSMMC and TPMMC eyes, respectively, a significant reduction from preoperative IOP in each group (p < 0.0005). Complete success was achieved at the ≤21 mm Hg target IOP in 10 (52.6%) and 14 (66.6%) eyes and qualified success in 15 (78.9%) and 18 (85.7%) eyes in the DSMMC and TPMMC groups, respectively. There were no differences in the Kaplan-Meier curves. Hypotony and shallow anterior chamber were significantly more frequent in the TPMMC group. Conclusions: Either procedure controlled IOP efficaciously at our endpoint. Low-dosage MMC can be considered a mild enhancement of deep sclerectomy IOP-lowering effect.
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.
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