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RECRUITING
NCT06997874
PHASE3

Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal

Sponsor: Queen's University, Belfast

View on ClinicalTrials.gov

Summary

Background and study aims The retina is the layer at the back of the eye that allows us to see. Sometimes, it can detach from the wall of the eye, causing a condition called rhegmatogenous retinal detachment (RRD), which leads to vision loss and requires surgery. The most common surgery for RRD is vitrectomy, but this can lead to complications like cataracts, which worsen over time and need to be removed with another surgery. Cataract surgery involves replacing the cloudy lens with a clear artificial one. Currently, it's unclear whether it's better to perform both surgeries at the same time or separately. The COMBAT study aims to find out which approach is best by comparing the outcomes of patients who have vitrectomy alone versus those who have both surgeries (vitrectomy and cataract surgery by phacoemulsification and intraocular lens \[IOL\] implantation) together. Who can participate? Adults aged 50 and older who have RRD but are not highly myopic (less than -6 diopters or an axial length of 26.5 mm or less) and have not had previous vitreoretinal surgery. Participants must be scheduled for a pars plana vitrectomy to repair their RRD. What does the study involve? Participants will be randomly assigned to one of two groups: one group will have vitrectomy first and, if needed, cataract surgery later; the other group will have both surgeries at the same time. The study will compare their vision, the number of successful retina reattachments, health related and visual related quality of life, patient satisfaction, complications, additional surgeries and procedures, and costs.

Official title: Clinical- and Cost-effectiveness, Safety and Acceptability of Sequential Vitrectomy and Cataract Surgery vs Combined Phacovitrectomy for Rhegmatogenous Retinal Detachment: Randomised Equivalence Trial

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2025-05-16

Completion Date

2028-05-08

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

PROCEDURE

Phacovitrectomy

Participants will undergo phacovitrectomy to remove the lens (phacoemulsification and intraocular lens implantation) and to repair the RRD (vitrectomy). Although a phacovitrectomy is done in the same manner whether the condition to be treated is macular hole or RRD, the calculations required for the surgeon to select which intraocular lens should be implanted are different if there is a RRD with a detached macula. For this reason, a Standard Operating Procedure (SOP) will be prepared for the phacovitrectomy group to guide surgeons on how to best determine the intraocular lens under these circumstances (17). Vitrectomy with any gauge size (e.g.23g, 25g, 27g) will be allowed for the surgery, as per standard care at the participating site. The choice of the tamponade agent will be at the discretion of the treating vitreoretinal surgeon, as per standard care.

PROCEDURE

Vitrectomy

Participants will receive vitrectomy to repair their RRD. The vitrectomy would be done as per standard care. Vitrectomy with any gauge size (e.g.23g, 25g, 27g) will be allowed for the surgery, as per standard care at the participating site. The choice of the tamponade agent will be at the discretion of the treating vitreoretinal surgeon, as per standard care. Then, if a cataract develops, phacoemulsification and intraocular lens implantation will be done as per standard clinical practice.

Locations (27)

Buckinghamshire Healthcare NHS Trust

Aylesbury, United Kingdom

Belfast Health and Social Care Trust

Belfast, United Kingdom

Sandwell and West Birmingham Hospitals NHS Trust

Birmingham, United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

County Durham and Darlington NHS Foundation Trust

Darlington, United Kingdom

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

The Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

University Hospitals Leicester NHS Trust

Leicester, United Kingdom

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Barts Health NHS Trust

London, United Kingdom

Guys & St Thomas NHS Foundation Trust

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

South Tees Hospitals NHS Foundation Trust

Middlesbrough, United Kingdom

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

South Tyneside and Sunderland NHS Trust

Sunderland, United Kingdom

Mid & South Essex NHS Foundation Trust

Westcliff-on-Sea, United Kingdom

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

York and Scarborough Teaching Hospitals NHS Foundation Trust

York, United Kingdom