Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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