Actively Recruiting

Phase 3
Age: 50Years +
All Genders
NCT06997874

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

Led by Queen's University, Belfast · Updated on 2025-05-30

276

Participants Needed

27

Research Sites

155 weeks

Total Duration

On this page

Sponsors

Q

Queen's University, Belfast

Lead Sponsor

N

Northern Ireland Clinical Trials Unit

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 50 years of age or older
  • Non-highly myopic phakic rhegmatogenous retinal detachment (less than -6 diopters and axial length 26.5 mm or less)
  • No previous vitreoretinal surgery
  • Scheduled for pars plana vitrectomy to repair their retinal detachment
Not Eligible

You will not qualify if you...

  • Presence of a formed or established cataract graded as nuclear sclerosis greater than 3 or cortical/posterior cataract involving the visual axis
  • Pseudophakia or aphakia
  • High myopia (greater than or equal to -6 diopters or axial length over 26.5 mm)
  • Giant retinal tear larger than 3 clock hours
  • Retinal dialysis
  • Participation in an investigational drug study
  • Declined consent for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

Buckinghamshire Healthcare NHS Trust

Aylesbury, United Kingdom

Actively Recruiting

2

Belfast Health and Social Care Trust

Belfast, United Kingdom

Not Yet Recruiting

3

Sandwell and West Birmingham Hospitals NHS Trust

Birmingham, United Kingdom

Not Yet Recruiting

4

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom

Not Yet Recruiting

5

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

Not Yet Recruiting

6

County Durham and Darlington NHS Foundation Trust

Darlington, United Kingdom

Not Yet Recruiting

7

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Not Yet Recruiting

8

Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

Not Yet Recruiting

9

The Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Not Yet Recruiting

10

University Hospitals Leicester NHS Trust

Leicester, United Kingdom

Not Yet Recruiting

11

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Not Yet Recruiting

12

Barts Health NHS Trust

London, United Kingdom

Not Yet Recruiting

13

Guys & St Thomas NHS Foundation Trust

London, United Kingdom

Not Yet Recruiting

14

King's College Hospital NHS Foundation Trust

London, United Kingdom

Not Yet Recruiting

15

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Not Yet Recruiting

16

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Not Yet Recruiting

17

South Tees Hospitals NHS Foundation Trust

Middlesbrough, United Kingdom

Not Yet Recruiting

18

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Not Yet Recruiting

19

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Not Yet Recruiting

20

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Not Yet Recruiting

21

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom

Not Yet Recruiting

22

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Not Yet Recruiting

23

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Not Yet Recruiting

24

South Tyneside and Sunderland NHS Trust

Sunderland, United Kingdom

Not Yet Recruiting

25

Mid & South Essex NHS Foundation Trust

Westcliff-on-Sea, United Kingdom

Not Yet Recruiting

26

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Not Yet Recruiting

27

York and Scarborough Teaching Hospitals NHS Foundation Trust

York, United Kingdom

Not Yet Recruiting

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Research Team

C

Colette Jackson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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