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Search / Trial NCT06997874

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

Launched by QUEEN'S UNIVERSITY, BELFAST · May 27, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Rhegmatogenous Retinal Detachment Phacovitrectomy Vitrectomy Cataract Vitreoretinal Surgery

ClinConnect Summary

The COMBAT study is a clinical trial aimed at understanding the best way to treat a serious eye condition called rhegmatogenous retinal detachment (RRD), which can lead to vision loss. The trial compares two approaches: one group of participants will undergo a surgery called vitrectomy to fix the retinal detachment, while another group will have both vitrectomy and cataract surgery at the same time. Cataract surgery is needed when the clear lens of the eye becomes cloudy, which can happen after vitrectomy. The study will look at how well each method works in terms of vision improvement, successful reattachment of the retina, quality of life, patient satisfaction, and possible complications.

To participate in this trial, you must be an adult aged 50 or older with RRD who hasn’t had any previous eye surgeries and does not have a severe form of nearsightedness. Participants will be randomly assigned to either have vitrectomy alone or both surgeries together. If you join the study, you can expect to have your vision and health closely monitored, and you'll contribute to valuable research that could help others in the future.

Gender

ALL

Eligibility 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

About Queen's University, Belfast

Queen's University Belfast is a prestigious research institution located in Northern Ireland, renowned for its commitment to advancing knowledge and improving health outcomes through innovative clinical research. The university actively engages in a diverse range of clinical trials, focusing on translational medicine and interdisciplinary collaboration to address pressing health challenges. With a strong emphasis on ethical standards and patient safety, Queen's University Belfast leverages its state-of-the-art facilities and a team of experienced researchers to contribute to the development of new therapies and enhance the understanding of various medical conditions.

Locations

Leeds, , United Kingdom

Birmingham, , United Kingdom

Sheffield, , United Kingdom

London, , United Kingdom

Belfast, , United Kingdom

Reading, , United Kingdom

Glasgow, , United Kingdom

Leicester, , United Kingdom

London, , United Kingdom

Southampton, , United Kingdom

Bristol, , United Kingdom

Bradford, , United Kingdom

Newcastle Upon Tyne, , United Kingdom

Oxford, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

London, , United Kingdom

Middlesborough, , United Kingdom

Wolverhampton, , United Kingdom

Plymouth, , United Kingdom

Liverpool, , United Kingdom

Hull, , United Kingdom

Aylesbury, , United Kingdom

Darlington, , United Kingdom

Sunderland, , United Kingdom

Westcliff On Sea, , United Kingdom

York, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Noemi Lois

Principal Investigator

Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported