Trial reportBMC ophthalmology2016
Biodegradable collagen matrix implant versus mitomycin-C in trabeculectomy: five-year follow-up.
Trial report in BMC ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Device-modified trabeculectomy for glaucoma.The Cochrane database of systematic reviews · 2023Pooled it
- Overview of cicatricial modulators in glaucoma fistulizing surgery.International ophthalmology · 2020Pooled it
- Pooled it
- Combined trabeculotomy-trabeculectomy with and without augmentation in primary congenital glaucoma: triple-armed randomized controlled trial.International ophthalmology · 2023Trial
- The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C.Ophthalmology · 2018Trial
- Management and outcomes of primary open-angle glaucoma.Journal of family medicine and primary care · 2026Review
- Efficacy of trabeculectomy combined with collagen implant and mitomycin C compared to with mitomycin C alone in glaucoma: a retrospective cohort study.International journal of ophthalmology · 2025Article
- Clinical Impact of the Use of Ologen in Filtering Surgery Performed in Uncontrolled Glaucoma.Journal of clinical medicine · 2024Article
- Pharmacological Approaches to Modulate the Scarring Process after Glaucoma Surgery.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Trabeculectomy: Does It Have a Future?Cureus · 2022Review
- Long-term perimetric stabilization with a management algorithm of set target intraocular pressure in different severities of primary angle-closure glaucoma.Indian journal of ophthalmology · 2021Article
- Comparison of bleb morphology by anterior segment optical coherence tomography and clinical outcome after phacotrabeculectomy with mitomycin C or Ologen implant.Indian journal of ophthalmology · 2021Article
- Cross-linked hyaluronic acid viscoelastic scleral implant in trabeculectomy.Indian journal of ophthalmology · 2021Article
- Ologen augmentation of Ahmed glaucoma drainage devices in pediatric glaucomas.BMC ophthalmology · 2021Article
- Does TRABECULECTOMY meet the 10-10-10 challenge in PACG, POAG, JOAG and Secondary glaucomas?International ophthalmology · 2020Article
- Trabeculectomy in pregnancy: Case studies and literature review.Indian journal of ophthalmology · 2020Review
- Surgical management of complicated inflammatory glaucoma.GMS ophthalmology cases · 2020Article
- Intracameral migration of collagen matrix implant.Indian journal of ophthalmology · 2019Article
- Five Years' Outcomes of Trabeculectomy with Cross-linked Sodium Hyaluronate Gel Implantation for Chinese Glaucoma Patients.Chinese medical journal · 2018Article
- Simplifying "target" intraocular pressure for different stages of primary open-angle glaucoma and primary angle-closure glaucoma.Indian journal of ophthalmology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.