Vitrectomy with or without Cataract Surgery for Eye Condition
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Recruiting
Phase 3Interventional Study
Rhegmatogenous Retinal Detachment
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
276 (estimated)
Sponsor
Queen's University, Belfast · Other
Who this trial is looking for
This trial is looking for adults aged 50 and older who have a specific eye condition called retinal detachment. Participants will be randomly assigned to receive either just vitrectomy or both vitrectomy and cataract surgery at the same time.
Are You a Good Fit for This Trial?
You may be able to join if
I am 50 years old or older
I have been diagnosed with retinal detachment
I do not have highly myopic vision
I have not had any previous eye surgery
I am scheduled for vitrectomy surgery
You may not be able to join if
I have an established cataract
I have had cataract surgery before
I have high myopia
I have a giant retinal tear
I have retinal dialysis
I am currently in another drug study
I have declined to participate
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 detachment (RRD), which leads to vision loss and requires surgery. The most common surgery for RRD is vitrectomy, but this can lead to complications like cataracts, which worsen over time and need to be …
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 detachment (RRD), which leads to vision loss and requires surgery. The most common surgery for RRD is vitrectomy, but this can lead to complications like cataracts, which worsen over time and need to be removed with another surgery. Cataract surgery involves replacing the cloudy lens with a clear artificial one. Currently, it's unclear whether it's better to perform both surgeries at the same time or separately. The COMBAT study aims to find out which approach is best by comparing the outcomes of patients who have vitrectomy alone versus those who have both surgeries (vitrectomy and cataract surgery by phacoemulsification and intraocular lens \[IOL\] implantation) together.
Who can participate? Adults aged 50 and older who have RRD but are not highly myopic (less than -6 diopters or an axial length of 26.5 mm or less) and have not had previous vitreoretinal surgery. Participants must be scheduled for a pars plana vitrectomy to repair their RRD.
What does the study involve? Participants will be randomly assigned to one of two groups: one group will have vitrectomy first and, if needed, cataract surgery later; the other group will have both surgeries at the same time. The study will compare their vision, the number of successful retina reattachments, health related and visual related quality of life, patient satisfaction, complications, additional surgeries and procedures, and costs.
Trial Locations
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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/establ…
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
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