Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
COMBAT
Clinical- and Cost-effectiveness, Safety and Acceptability of Sequential Vitrectomy and Cataract Surgery vs Combined Phacovitrectomy for Rhegmatogenous Retinal Detachment: Randomised Equivalence Trial
2 other identifiers
interventional
276
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2025
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2025
CompletedStudy Start
First participant enrolled
May 16, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 8, 2028
May 30, 2025
May 1, 2025
3 years
May 8, 2025
May 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best-Corrected Visual Acuity (BCVA)
Change in Best-Corrected Visual Acuity (BCVA) in the affected study eye from baseline to 52 weeks (+/- 6 weeks) after surgery (equivalence margin +/- 7 ETDRS letters)
52 weeks (+/- 6 weeks) after surgery
Secondary Outcomes (16)
Primary anatomical success
52 weeks (+/- 6 weeks) after surgery
Final anatomical success
52 weeks (+/- 6 weeks) after surgery
Intraoperative complications
By 52 weeks (+/- 6 weeks) after surgery
Postoperative complications
By 52 weeks (+/- 6 weeks) after surgery
Surgery
By 52 weeks (+/- 6 weeks) after surgery
- +11 more secondary outcomes
Study Arms (2)
Phacovitrectomy
ACTIVE COMPARATORVitrectomy
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adults ≥50 years of age
- Non-highly myopic (\< -6 diopters; ≤26.5 mm axial length) phakic RRD
- Naive to previous vitreoretinal surgery
- Pars plana vitrectomy is planned to repair their RRD
You may not qualify if:
- Presence of a "formed/established cataract." A "formed/established cataract" is defined as a cataract that, based on the Age-Related Eye Disease Study (AREDS) Research Group, is graded as nuclear sclerosis of \>3 and/or if there is an anterior cortical cataract and/or a subcapsular posterior cataract involving the visual axis.
- Pseudophakia or aphakia
- High myopia (≥ -6 diopters; \>26.5 mm axial length)
- Giant retinal tear (i.e. presence of one or more retinal tears of \>3 clock hours in size)
- Retinal dialysis
- Declined consent for participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's University, Belfastlead
- Northern Ireland Clinical Trials Unitcollaborator
Study Sites (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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noemi Lois
Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor of Ophthalmology
Study Record Dates
First Submitted
May 8, 2025
First Posted
May 30, 2025
Study Start
May 16, 2025
Primary Completion (Estimated)
May 8, 2028
Study Completion (Estimated)
May 8, 2028
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- Following publication of the primary and secondary outcomes and after data has been fully exploited by the COMBAT research team, there may be scope to conduct additional analyses on the data collected. In such instances, formal requests for data will need to be made in writing to the Chief Investigator via the NICTU. If there are requests for data sharing, these will be reviewed on a case-by-case basis by the CI and NICTU (Northern Ireland Clinical Trials Unit, 7 Lennoxvale, Belfast, UK) with approval by the Sponsor required before data are shared.
Following publication of the primary and secondary outcomes and after data has been fully exploited by the COMBAT research team, there may be scope to conduct additional analyses on the data collected. In such instances, formal requests for data will need to be made in writing to the Chief Investigator via the NICTU. If there are requests for data sharing, these will be reviewed on a case-by-case basis by the CI and NICTU (Northern Ireland Clinical Trials Unit, 7 Lennoxvale, Belfast, UK) with approval by the Sponsor required before data are shared.