| Trial Acronym | COMBAT |
| Clinical Area | Ophthalmology |
| Trial Title | Clinical- and cost-effectiveness, safety, and acceptability of COMBined phacovitrectomy, versus sequentiAl viTrectomy and cataract surgery, for the management of rhegmatogenous retinal detachment: A Randomised Equivalence Clinical Trial. |
| Status | Set Up |
| Trial Registration |
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Recruitment
Recruitment Target 276 Date Open to Recruitment Recruitment Date Closed to Recruitment -
Trial Design
Trial Design Pragmatic randomised equivalence trial. Study Aim Aim To determine whether, in people with non-highly myopic phakic rhegmatogenous retinal detachment (RRD) (Population), phacovitrectomy (Intervention) is equivalent (equivalence margin +/- 7 Early Treatment Diabetic Retinopathy Study ETDRS letters) to vitrectomy and subsequent cataract surgery (phacoemulsification) if/when needed (Comparator) for improving vision following surgery (primary Outcome) but superior for other (secondary) outcomes (as listed in this protocol) in the 12 months after surgery.
Objectives
To determine if, in people presenting with non-highly myopic phakic RRD, phacovitrectomy (i.e. removing the cataract and doing vitrectomy to repair the RRD) is as good or better as doing only the retinal detachment repair with vitrectomy and then, if and when the cataract develops, doing a phaco (i.e. cataract surgery) and to assess post-trial implementation strategies and scalability.
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Chief Investigator (CI)
Chief Investigator Professor Noemi Lois, Queen’s University Belfast -
Sponsor(s) & Funder(s)
Sponsor Queens University Belfast Funder National Institute for Health and Care Research
Health Technology Assessment Programme; NIHR161891