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

BMC Ophthalmology

Study Protocol

Carmen D. Dirksen¹  Peter W. T. de Waard²  Bjorn Winkens³  Laurentius J. van Rijn⁴  Paul J. G. Ernest⁵  Benjamin J. Pijl⁶  Wishal D. Ramdas⁷  Annelie Tan⁸  Rogier P. H. M. Müskens⁹  Frank J. H. M. van den Biggelaar^1,10  Lotte M. J. Scheres^1,10  Henny J. M. Beckers^1,10  Stefani Kujovic-Aleksov^1,11  Ronald M. P. C. de Crom^1,11 

[1] Department of Clinical Epidemiology and Medical Technology Assessment, CAPHRI School for Public Health and Primary Care, Maastricht University Medical Centre, Maastricht, The Netherlands;Department of Glaucoma, Rotterdam Eye Hospital, Rotterdam, The Netherlands;Department of Methodology and Statistics, Faculty of Health, Medicine and Life Sciences (FHML), Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands;Department of Ophthalmology, Amsterdam University Medical Centre, Amsterdam, The Netherlands;Department of Ophthalmology, Bravis Hospital, Bergen op Zoom, The Netherlands;Department of Ophthalmology, Deventer Hospital, Deventer, The Netherlands;Department of Ophthalmology, Erasmus Medical Centre, Rotterdam, The Netherlands;Department of Ophthalmology, Leiden University Medical Centre, Leiden, The Netherlands;Department of Ophthalmology, University Medical Centre Groningen, Groningen, The Netherlands;University Eye Clinic Maastricht, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands;University Eye Clinic Maastricht, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands;Department of Ophthalmology, Zuyderland Medical Centre, Heerlen, The Netherlands;

关键词: MicroShunt;    Trabeculectomy;    Novel bleb-forming glaucoma surgery;    Glaucoma;    Intraocular pressure;    Patient reported outcome measures;    Randomized controlled trial;    Cost-effectiveness;    Budget impact;   

DOI  :  10.1186/s12886-022-02734-y

 received in 2022-10-19, accepted in 2022-12-10,  发布年份 2022

来源: Springer

【 摘 要 】

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.DiscussionThis 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.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 4