Evidence map›Paper›PMID 21921953›Full record

Trial reportEye (London, England)2011

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

S Cillino, F Di Pace, G Cillino, A Casuccio

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Eye (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03782051 (Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy), which is not on this map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
5.2field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03782051 nacompletednot on this mapstarted 2013, after this paper: background citation

Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy

TypeinterventionalSponsorZagazig UniversityRan2013 to 2018Enrolled81ConditionsPrimary Open-angle GlaucomaArmscombined phacoemulsification and viscocanalostomy, combined phacoemulsification and viscocanalostomy and ologen
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Device-modified trabeculectomy for glaucoma.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Device-modified trabeculectomy for glaucoma.The Cochrane database of systematic reviews · 2015
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  20. [Management of Radius-Maumenee syndrome : Treatment with deep sclerectomy, viscocanalostomy and collagen matrix implantation].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2016
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

S CillinoDepartment of Experimental Biomedicine and Clinical Neuroscience, Ophthalmology Section, University of Palermo (Italy), Palermo, Italy. cillino@unipa.it
F Di Pace
G Cillino
A Casuccio
University of Palermo · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

methodsThis 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.

resultsThe 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.

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

Indexed as

Absorbable ImplantsAgedCollagenCross-Linking ReagentsFemaleGlaucomaGlycosaminoglycansHumansIntraocular PressureIntraoperative CareMaleMiddle AgedMitomycinProspective StudiesProstheses and ImplantsTomography, Optical CoherenceCollagencollagen-glycosaminoglycan copolymerCross-Linking ReagentsGlycosaminoglycansMitomycin

Identifiers

PMID21921953
PMCPMC3234465
OpenAlexW2091701340

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.