Status:
RECRUITING
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Lead Sponsor:
Queen's University, Belfast
Collaborating Sponsors:
Northern Ireland Clinical Trials Unit
Conditions:
Rhegmatogenous Retinal Detachment
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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 det...
Detailed Description
Background Rhegmatogenous retinal detachment (RRD) is the separation of the retina from the wall of the eye, where it is normally attached. It affects 10-18 people per 100,000 per year. Thus, in the U...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 8 2028
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT06997874
Start Date
May 16 2025
End Date
May 8 2028
Last Update
May 30 2025
Active Locations (27)
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1
Buckinghamshire Healthcare NHS Trust
Aylesbury, United Kingdom
2
Belfast Health and Social Care Trust
Belfast, United Kingdom
3
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham, United Kingdom
4
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom