Comparing vitrectomy alone to vitrectomy with cataract removal for retinal detachment
Clinical- and Cost-effectiveness, Safety and Acceptability of Sequential Vitrectomy and Cataract Surgery vs Combined Phacovitrectomy for Rhegmatogenous Retinal Detachment: Randomised Equivalence Trial
PHASE3 · Queen's University, Belfast · NCT06997874
This study is testing whether doing just vitrectomy or adding cataract removal helps older adults with retinal detachment see better and have fewer problems after surgery.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Queen's University, Belfast (other) |
| Locations | 27 sites (Aylesbury and 26 other locations) |
| Trial ID | NCT06997874 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the best surgical approach for treating rhegmatogenous retinal detachment (RRD) in adults aged 50 and older who have not previously undergone cataract surgery. It compares outcomes between patients receiving only vitrectomy and those undergoing a combined procedure of vitrectomy and cataract removal. The study will assess the effectiveness of each approach in terms of retinal reattachment and vision improvement. Participants will be monitored for complications and overall visual outcomes following their respective surgeries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 and older with rhegmatogenous retinal detachment who are not highly myopic and have not had previous vitreoretinal surgery.
Not a fit: Patients with established cataracts, high myopia, or those who have undergone previous vitreoretinal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical strategies that enhance vision recovery and reduce complications for patients with retinal detachment.
How similar studies have performed: While there is limited data on combined vitrectomy and cataract surgery for RRD, previous studies suggest that vitrectomy alone is effective, making this approach a potentially novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Inclusion in an investigational drug study * Declined consent for participation
Where this trial is running
Aylesbury and 26 other locations
- Buckinghamshire Healthcare NHS Trust — Aylesbury, United Kingdom (RECRUITING)
- Belfast Health and Social Care Trust — Belfast, United Kingdom (NOT_YET_RECRUITING)
- Sandwell and West Birmingham Hospitals NHS Trust — Birmingham, United Kingdom (NOT_YET_RECRUITING)
- Bradford Teaching Hospitals NHS Foundation Trust — Bradford, United Kingdom (NOT_YET_RECRUITING)
- University Hospitals Bristol NHS Foundation Trust — Bristol, United Kingdom (NOT_YET_RECRUITING)
- County Durham and Darlington NHS Foundation Trust — Darlington, United Kingdom (NOT_YET_RECRUITING)
- NHS Greater Glasgow & Clyde — Glasgow, United Kingdom (NOT_YET_RECRUITING)
- Hull University Teaching Hospitals NHS Trust — Hull, United Kingdom (NOT_YET_RECRUITING)
- The Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (NOT_YET_RECRUITING)
- University Hospitals Leicester NHS Trust — Leicester, United Kingdom (NOT_YET_RECRUITING)
- Liverpool University Hospitals NHS Foundation Trust — Liverpool, United Kingdom (NOT_YET_RECRUITING)
- Barts Health NHS Trust — London, United Kingdom (NOT_YET_RECRUITING)
- Guys & St Thomas NHS Foundation Trust — London, United Kingdom (NOT_YET_RECRUITING)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (NOT_YET_RECRUITING)
- Moorfields Eye Hospital NHS Foundation Trust — London, United Kingdom (NOT_YET_RECRUITING)
- Manchester University NHS Foundation Trust — Manchester, United Kingdom (NOT_YET_RECRUITING)
- South Tees Hospitals NHS Foundation Trust — Middlesbrough, United Kingdom (NOT_YET_RECRUITING)
- Newcastle Upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, United Kingdom (NOT_YET_RECRUITING)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (NOT_YET_RECRUITING)
- University Hospitals Plymouth NHS Trust — Plymouth, United Kingdom (NOT_YET_RECRUITING)
- Royal Berkshire NHS Foundation Trust — Reading, United Kingdom (NOT_YET_RECRUITING)
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (NOT_YET_RECRUITING)
- University Hospital Southampton NHS Foundation Trust — Southampton, United Kingdom (NOT_YET_RECRUITING)
- South Tyneside and Sunderland NHS Trust — Sunderland, United Kingdom (NOT_YET_RECRUITING)
- Mid & South Essex NHS Foundation Trust — Westcliff-on-Sea, United Kingdom (NOT_YET_RECRUITING)
- The Royal Wolverhampton NHS Trust — Wolverhampton, United Kingdom (NOT_YET_RECRUITING)
- York and Scarborough Teaching Hospitals NHS Foundation Trust — York, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Noemi Lois — Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK
- Study coordinator: Colette Jackson
- Email: colette.jackson@nictu.hscni.net
- Phone: +44 28 96151447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rhegmatogenous Retinal Detachment, Rhegmatogenous retinal detachment, phacovitrectomy, vitrectomy, cataract, vitreoretinal surgery