Evidence map›Paper›PMID 28034308›Full record

Trial reportBMC ophthalmology2016

Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial.

Angelo P Tanna, Alfred W Rademaker, C Gustavo de Moraes, David G Godfrey, Steven R Sarkisian, Steven D Vold, Robert Ritch

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01440751 (Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT01440751 phase4completednot on this map

Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery

TypeinterventionalSponsorAeon Astron Europe B.V.Ran2011 to 2015Enrolled99ConditionsGlaucomaArmsUse of ologen Collagen Matrix in trabeculectomy (ologen), Use of Mitomycin-C (MMC) in trabeculectomy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Ethics of Glaucoma Widgets.Journal of current glaucoma practice
    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

7 authors at 5 institutions in 1 country.

Angelo P TannaDepartment of Ophthalmology, Northwestern University Feinberg School of Medicine, 645 N. Michigan Ave., Suite 440, Chicago, IL, 60611, USA. atanna@northwestern.edu.
Alfred W RademakerDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
C Gustavo de MoraesEdward S. Harkness Eye Institute, Columbia University Medical Center, New York, USA.
David G GodfreyGlaucoma Associates of Texas, Dallas, TX, USA.
Steven R SarkisianDean McGee Eye Institute, Oklahoma City, OK, USA.
Steven D VoldVold Vision, Fayetteville, AR, USA.
Robert RitchEinhorn Clinical Research Center, New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA.
Northwestern University · USColumbia University Irving Medical Center · USDean McGee Eye Institute · USGlaucoma Associates of Texas · USNew York Eye and Ear Infirmary · US

Funding

Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
NCATS NIH HHS UL1 TR001422
6 · The paper itself

Abstract

backgroundAntifibrotic agents are commonly utilized to enhance the success rates of trabeculectomy. Novel approaches to further improve success rates and reduce the risks of complications are needed. The purpose of this study was to compare intraocular pressure (IOP)-lowering efficacy and safety of trabeculectomy or combined phacoemulsification and trabeculectomy with mitomycin-C (MMC) vs. Collagen Matrix (CM).

methodsA prospective, multicenter, randomized controlled trial was performed. Ninety-five eyes of 94 patients with uncontrolled glaucoma despite medical therapy, without previous incisional glaucoma surgery underwent trabeculectomy (85 eyes) or combined phacoemulsification and trabeculectomy (10 eyes) and were randomized to MMC or CM. One eye of each subject was analyzed. Patients were followed for 24 months. The criteria for complete success were IOP >5 and ≤21 mmHg with at least a 20% reduction below medicated baseline without additional glaucoma surgery or medications. The main outcome measures were complete success rates at 24 months with Kaplan-Meier analysis and incidence of adverse events.

resultsThe baseline IOPs were 20.4 ± 6.0 mmHg and 21.2 ± 6.1 (mean ± standard deviation, p = 0.49) on 3.2 ± 1.1 and 3.1 ± 1.0 medications (p = 0.53) compared to 11.8 ± 5.2 and 12.8 ± 3.7 (p = 0.36) on 0.5 ± 0.8 and 0.6 ± 1.0 medications (p = 0.63) at 2 years in the MMC and CM groups, respectively. Kaplan-Meier analysis demonstrated complete success rates were similar in both groups at 24 months: 38.4 ± 7.6% with MMC and 56.2 ± 7.9% with CM (mean ± standard error, p = 0.112, log rank test); however, a significantly higher incidence of failure due to persistent hypotony was observed with MMC (p = 0.002).

conclusionsUse of the CM implant at the time of trabeculectomy or combined phacoemulsification and trabeculectomy is associated with similar complete success rates compared to adjunctive MMC; however, the risk of persistent hypotony is higher with MMC.

trial registrationClinicalTrials.gov registration number NCT01440751 . Registered 9/14/11.

Indexed as

PhacoemulsificationAgedAntifibrinolytic AgentsAntihypertensive AgentsCollagenCombined Modality TherapyFemaleGlaucomaHumansIntraocular PressureKaplan-Meier EstimateMaleMiddle AgedMitomycinProspective StudiesTrabeculectomyAntifibrinolytic AgentsAntihypertensive AgentsCollagenMitomycin

Identifiers

PMID28034308
PMCPMC5200961
OpenAlexW2563291840

What OpenQuestion holds

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LicenceCC BY
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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.