Background: Trabeculectomy 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. Methods: A 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 registration: ClinicalTrials.gov, Identifier: NCT03931564, Registered 30 April 2019.
|Publication status||Published - 31 Jan 2023|
Bibliographical noteFunding Information:
This is an investigator-initiated trial, of which Maastricht University Medical Center is the sponsor (contact information: prof. H.J.M. Beckers, Department of Ophthalmology, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands, Tel: + 31433871594). This study is supported by a research grant from ZonMw, a Dutch organization for Health Research and Innovation, programme ‘Doelmatigheidsonderzoek’ project number: 852001908. Additional funding was obtained from “Stichting Wetenschappelijk Onderzoek Oogziekenhuis (SWOO) prof. Dr. H.J.Flieringa Stichting”. The study protocol was reviewed by ZonMw and SWOO before allocating the grants. Funding agencies were not involved in the design of the study and will not have any role during its execution, analysis, or interpretation of the data.
© 2023, The Author(s).