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Background <p>Rhegmatogenous retinal detachment (RRD) is a potentially blinding condition that affects ~ 1 in 10,000 adults per year. Retinal detachment surgery usually involves internal reapposition of the retina using the injection of a gas tamponade into the vitreous cavity. However, this has downsides including delayed visual recovery, the need to posture postoperatively, limiting fundal view during postoperative monitoring, and the risk of raised intraocular pressure. We examine a novel surgical variation, using a temporary suprachoroidal viscobuckle (SCVB) instead of gas. SCVB involves the controlled injection of high viscosity viscoelastic through an external scleral incision into the suprachoroidal space to create an indent under a causative retinal break. The sodium hyaluronate viscoelastic is resorbed over 2–3 weeks, long enough for intraoperative laser retinopexy to cause chorioretinal adhesion. The primary objective of this study is to establish if it is feasible to recruit, retain, and evaluate patients with RRD into a larger randomised controlled trial of SCVB. Secondary objectives are to make a preliminary assessment of safety and efficacy.</p> Methods <p>This multicentre, randomised, controlled, two-group, unmasked feasibility trial recruits participants with primary RRD and a break or breaks within 1 clock hour. The CE-marked sodium hyaluronate viscobuckle is created during otherwise standard pars plana vitrectomy RRD surgery. Feasibility outcomes include screen failure rate, rate of recruitment, protocol compliance, and participant retention. The main efficacy outcome is retinal attachment with no intravitreal tamponade present and no subretinal fluid which could spread, without the need for further surgery, at week 12. The key secondary efficacy outcome is Early Treatment of Diabetic Retinopathy Study best-corrected visual acuity at week 24. Safety is recorded through adverse events and serious adverse events.</p> Discussion <p>SCVB has multiple potential advantages for patients. This study will help determine if a definitive study of SCVB is justified and deliverable and inform its design.</p> Trial registration <p>ClinicalTrials.gov Identifier: NCT04557527, registered 09 September 2020.</p>

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Suprachoroidal VIsco-bucKlING versus gas tamponade for the treatment of rhegmatogenous retinal detachment (VIKING): study protocol for a multi-centre, randomised, controlled feasibility study

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  • 发表日期：

    2026年3月17日

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  • Shohista Saidkasimova,
  • Chan Ning Lee,
  • George S. P. Murphy,
  • Timothy L. Jackson,
  • Aman Chandra,
  • Kurt Spiteri Cornish,
  • Riti Desai,
  • Kirsteen Houghton,
  • David A Laidlaw,
  • David Steel,
  • Noimot Timson

摘要

Background

Rhegmatogenous retinal detachment (RRD) is a potentially blinding condition that affects ~ 1 in 10,000 adults per year. Retinal detachment surgery usually involves internal reapposition of the retina using the injection of a gas tamponade into the vitreous cavity. However, this has downsides including delayed visual recovery, the need to posture postoperatively, limiting fundal view during postoperative monitoring, and the risk of raised intraocular pressure. We examine a novel surgical variation, using a temporary suprachoroidal viscobuckle (SCVB) instead of gas. SCVB involves the controlled injection of high viscosity viscoelastic through an external scleral incision into the suprachoroidal space to create an indent under a causative retinal break. The sodium hyaluronate viscoelastic is resorbed over 2–3 weeks, long enough for intraoperative laser retinopexy to cause chorioretinal adhesion. The primary objective of this study is to establish if it is feasible to recruit, retain, and evaluate patients with RRD into a larger randomised controlled trial of SCVB. Secondary objectives are to make a preliminary assessment of safety and efficacy.

Methods

This multicentre, randomised, controlled, two-group, unmasked feasibility trial recruits participants with primary RRD and a break or breaks within 1 clock hour. The CE-marked sodium hyaluronate viscobuckle is created during otherwise standard pars plana vitrectomy RRD surgery. Feasibility outcomes include screen failure rate, rate of recruitment, protocol compliance, and participant retention. The main efficacy outcome is retinal attachment with no intravitreal tamponade present and no subretinal fluid which could spread, without the need for further surgery, at week 12. The key secondary efficacy outcome is Early Treatment of Diabetic Retinopathy Study best-corrected visual acuity at week 24. Safety is recorded through adverse events and serious adverse events.

Discussion

SCVB has multiple potential advantages for patients. This study will help determine if a definitive study of SCVB is justified and deliverable and inform its design.

Trial registration

ClinicalTrials.gov Identifier: NCT04557527, registered 09 September 2020.