Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment

Not Applicable

Recruiting

• Conditions: Retinal Detachment With Break
• Interventions: Procedure: Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade; Device: Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)

• Registration Number: NCT04557527
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

The study compares standard surgery for retinal detachment (RD) (vitrectomy, cryotherapy and gas) with a surgical variation that replaces the intraocular gas tamponade with suprachoroidal injection of viscoelastic underneath the break that caused the retinal detachment.

Detailed Description

After being informed about the study and the potential risks, the eligible patients who have given written consent to the treatment will be randomized into treatment (vitrectomy, cryo and gas) or control (viscobuckle vitrectomy) group.

Study Timeline

• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Study Start: 2022-02-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients requiring pars plana vitrectomy for the treatment of primary rhegmatogenous retinal detachment (RD) caused by a single break, or multiple breaks within one clock hour. The final determination of qualifying breaks is made at the time of surgery following 360-degree, internal, indented search using a wide-angle viewing system.

Exclusion Criteria

• Hypersensitivity to hyaluronate or. HEALON5® PRO OVD
• Participation in another interventional study within 8 weeks of enrolment or planned to occur during this study.
• Bleeding disorders or the use of anticoagulants (such as warfarin, rivaroxaban) or dual anti-platelet drugs such as aspirin with clopidogrel. Monotherapy with low dose (≤100 mg) aspirin is permitted, and if clinically appropriate this should be stopped prior to surgery and recommenced only after satisfactory day 1 post-operative review.
• Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial.
• Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol, such as dementia, mental illness, or serious systemic medical disease.

Study eye:

• Presence of proliferative vitreoretinopathy (PVR) or any tractional RD
• Previous vitreoretinal surgery, open-globe injury or endophthalmitis
• Aphakia
• Previous or current congenital cataract
• Previous or current suprachoroidal haemorrhage
• Congenital or acquired ocular, orbital or periocular abnormality that, in the opinion of the attending vitreoretinal surgeon, would preclude the safe delivery of Healon 5 into the suprachoroidal space (detail the specific reason for exclusion in the source documents)
• Presence of other ocular co-morbidity that, in the opinion of the investigator, is likely to prevent an accurate assessment of retinal attachment
• Current intraocular inflammation other than mild cellular activity thought to be secondary to RD
• Current ocular or periocular infection other than blepharitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade	Pars plana vitrectomy, retinopexy with laser or cryotherapy, and intravitreal gas tamponade.
treatment	Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)	Pars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle.

Primary Outcome Measures

Name	Time	Method
To make a preliminary assessment of safety and efficacy of suprachoroidal viscobuckle.	2 years	feasibility trial
To establish if it is feasible to recruit, retain, and evaluate patients with RD into a larger randomised controlled trial of vitrectomy and suprachoroidal viscobuckle.	2 years	feasibility trial

Trial Locations

Locations (6)

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom

Sunderland Eye Infimary; 🇬🇧 Sunderland, Tyne And Wear, United Kingdom

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Southend University Hospital NHS Foundation Trust; 🇬🇧 Southend, United Kingdom

Norfolk and Norwich University Foundation Trust; 🇬🇧 Norwich, United Kingdom

Guy's & St. Thomas' Hospital NHS Foundatrion Trust; 🇬🇧 London, United Kingdom