Evidence map›Paper›PMID 36721130›Full record

ArticleBMC ophthalmology2023

Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial.

Lotte M J Scheres, Frank J H M van den Biggelaar, Bjorn Winkens, Stefani Kujovic-Aleksov, Rogier P H M Müskens, Peter W T de Waard, Ronald M P C de Crom, Paul J G Ernest, Benjamin J Pijl, Wishal D Ramdas and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03931564 (SIGHT Study), 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
–field-weighted citation impact
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.

NCT03931564 naunknown statusnot on this map

SIGHT Study: Cost-effectiveness of InnFocus Microshunt (IMS) Implantation Versus Standard Trabeculectomy (TE)

TypeinterventionalSponsorMaastricht University Medical CenterRan2020 to 2024Enrolled124ConditionsPrimary Open-angle GlaucomaArmsPRESERFLO Microshunt implantation, Trabeculectomy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. 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

14 authors.

Lotte M J ScheresUniversity Eye Clinic Maastricht, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands. l.scheres@maastrichtuniversity.nl.ORCID http://orcid.org/0000-0002-0262-0540
Frank J H M van den BiggelaarUniversity Eye Clinic Maastricht, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
Bjorn WinkensDepartment of Methodology and Statistics, Faculty of Health, Medicine and Life Sciences (FHML), Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.
Stefani Kujovic-AleksovUniversity Eye Clinic Maastricht, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
Rogier P H M MüskensDepartment of Ophthalmology, University Medical Centre Groningen, Groningen, The Netherlands.
Peter W T de WaardDepartment of Glaucoma, Rotterdam Eye Hospital, Rotterdam, The Netherlands.
Ronald M P C de CromUniversity Eye Clinic Maastricht, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
Paul J G ErnestDepartment of Ophthalmology, Bravis Hospital, Bergen op Zoom, The Netherlands.
Benjamin J PijlDepartment of Ophthalmology, Deventer Hospital, Deventer, The Netherlands.
Wishal D RamdasDepartment of Ophthalmology, Erasmus Medical Centre, Rotterdam, The Netherlands.
Laurentius J van RijnDepartment of Ophthalmology, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
Annelie TanDepartment of Ophthalmology, Leiden University Medical Centre, Leiden, The Netherlands.
Carmen D DirksenDepartment of Clinical Epidemiology and Medical Technology Assessment, CAPHRI School for Public Health and Primary Care, Maastricht University Medical Centre, Maastricht, The Netherlands.
Henny J M BeckersUniversity Eye Clinic Maastricht, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrabeculectomy is the "gold standard" initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective.

methodsA multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. DISCUSSION: This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective.

trial registrationClinicalTrials.gov, Identifier: NCT03931564 , Registered 30 April 2019.

Indexed as

Glaucoma, Open-AngleTrabeculectomyCost-Benefit AnalysisEquivalence Trials as TopicEyeHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTonometry, OcularBudget impactCost-effectivenessGlaucomaIntraocular pressureMicroShuntNovel bleb-forming glaucoma surgeryPatient reported outcome measuresRandomized controlled trialTrabeculectomy

Identifiers

PMID36721130
PMCPMC9887798

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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.