Actively Recruiting

Phase 3
Age: 50Years +
All Genders
ID06997874

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

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

276

Participants Needed

27

Research Sites

N/A

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

This research focuses on adults aged 50 and older with rhegmatogenous retinal detachment (RRD), a condition where the retina detaches from the back of the eye and can cause vision loss. The study compares two surgical approaches: performing vitrectomy alone versus combining vitrectomy with cataract surgery (phacoemulsification and intraocular lens implantation) at the same time. The goal is to find out which method leads to better vision outcomes, fewer surgeries, improved quality of life, patient satisfaction, and cost-effectiveness over one year. Participants will be randomly assigned to one of two groups. One group will have vitrectomy first and receive cataract surgery later if needed, while the other group will have both vitrectomy and cataract removal together in a single procedure called phacovitrectomy. The surgeries will be done according to standard care, with decisions on surgical tools and tamponade agents left to the surgeons. The study also includes an internal pilot phase to assess recruitment feasibility and collects detailed information to support future implementation of the preferred treatment approach. During the trial, participants will undergo vision assessments including best-corrected visual acuity at 52 weeks after surgery. Other evaluations will include anatomical success of retinal reattachment, complications during and after surgery, refractive error measurements, quality of life questionnaires, patient experience interviews, and health and social care usage. Data will be collected through clinical visits and questionnaires over the 52-week follow-up period to carefully monitor safety, effectiveness, and patient satisfaction.

CONDITIONS

Brief 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; axial length 26.5 mm or less)
  • No previous vitreoretinal surgery
  • Scheduled for pars plana vitrectomy to repair retinal detachment
Not Eligible

You will not qualify if you...

  • Presence of a formed/established cataract graded as nuclear sclerosis greater than 3 or involving the visual axis
  • Previous cataract surgery (pseudophakia) or absence of lens (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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day and immediate post-operative period

Participants will undergo surgery to repair retinal detachment. They will receive either vitrectomy alone or combined phacovitrectomy to remove the lens and repair the retinal detachment.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to 52 weeks (+/- 6 weeks) after surgery

Participants are monitored after surgery for up to 52 weeks to assess vision, anatomical success, complications, and participant experience.

Multiple follow-up visits over 52 weeks

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

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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