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Contact Information:

Colette Jackson +44 28 96151447
colette.jackson@nictu.hscni.net


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Be Part of Research - Trial Details - Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal

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

Medical Conditions

Cataract
Retinal Detachment
Dissociative Disorders


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

May 2025 May 2028

INTERVENTIONAL

Intervention Type : PROCEDURE
Intervention Description : 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.

Intervention Arm Group : Phacovitrectomy;

Intervention Type : PROCEDURE
Intervention Description : 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.

Intervention Arm Group : Vitrectomy;


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.

You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Belfast Health and Social Care Trust
    Belfast
  • Sheffield Teaching Hospitals NHS Foundation Trust
    Sheffield
  • University Hospital Southampton NHS Foundation Trust
    Southampton
  • Barts Health NHS Trust
    London
  • The Royal Wolverhampton NHS Trust
    Wolverhampton
  • Oxford University Hospitals NHS Foundation Trust
    Oxford
  • University Hospitals Bristol NHS Foundation Trust
    Bristol
  • The Leeds Teaching Hospitals NHS Trust
    Leeds
  • NHS Greater Glasgow & Clyde
    Glasgow
  • University Hospitals Plymouth NHS Trust
    Plymouth
  • Sandwell and West Birmingham Hospitals NHS Trust
    Birmingham
  • Manchester University NHS Foundation Trust
    Manchester
  • Liverpool University Hospitals NHS Foundation Trust
    Liverpool
  • Bradford Teaching Hospitals NHS Foundation Trust
    Bradford
  • South Tees Hospitals NHS Foundation Trust
    Middlesborough
  • Moorfields Eye Hospital NHS Foundation Trust
    London
  • County Durham and Darlington NHS Foundation Trust
    Darlington
  • Hull University Teaching Hospitals NHS Trust
    Hull
  • Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Newcastle Upon Tyne
  • Buckinghamshire Healthcare NHS Trust
    Aylesbury
  • Guys & St Thomas NHS Foundation Trust
    London
  • University Hospitals Leicester NHS Trust
    Leicester
  • King's College Hospital NHS Foundation Trust
    London
  • Royal Berkshire NHS Foundation Trust
    Reading
  • South Tyneside and Sunderland NHS Trust
    Sunderland
  • Mid & South Essex NHS Foundation Trust
    Westcliff on sea
  • York and Scarborough Teaching Hospitals NHS Foundation Trust
    York


The study is sponsored by Queen's University, Belfast and is in collaboration with Northern Ireland Clinical Trials Unit.




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Read full details for Trial ID: NCT06997874
Last updated 27 May 2025

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