Clinical Trials Directory

Trials / Completed

CompletedNCT04557527

Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment

Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment: A Randomized, Controlled, Feasibility Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
King's College Hospital NHS Trust · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponadeConventional pars plana vitrectomy procedure is used to treat rhegmatogenous retinal detachment- laser or cryo retinopexy intraocular gas tamponade (SF6, C2F6 or C3F8) are chosen according to the number and size of the causative retinal break(s) and surgeons clinical judgement
DEVICESuprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)After drainage of subretinal fluid, approximately 0.5 ml of Healon 5 is injected in to the suprachoroidal space underlying the retinal break. Laser retinopexy is applied around the break .

Timeline

Start date
2022-02-07
Primary completion
2024-12-31
Completion
2025-04-30
First posted
2020-09-21
Last updated
2025-08-06

Locations

6 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04557527. Inclusion in this directory is not an endorsement.