COMBAT: 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
Rhegmatogenous retinal detachment
Following consent, participants will be reviewed by the research team, including their surgeon. Previous medical and eye history will be reviewed, and measurements of the eye and baseline data (including 5 questionnaires) will then be collected. Patients will then be seen again at 1, 6, 12, and 52 weeks (+/- 6 weeks) post-surgery for the measurements and baseline data collection. Participation in the study will end following the 52-week visit. Participants will also have the option at their initial study discussion to give consent to be contacted in the future to take part in individual interviews to talk about their opinions and experiences of treatment. The study PPI group gave favorable feedback about the proposed options for the consenting process (written/verbal) for interviews. Participants can receive an audio recording of their consent if they request this. A total of 3 (maximum) individual interviews will be undertaken by the participant. Health care professionals will also be invited to give online consent to take part in an individual/small group discussion to share their views on the barriers and facilitators involved in the implementation of the COMBAT study. Studies within a Trial (SWAT) There will be 2 SWATs embedded in the trial: SWAT A - Will record the proportion in each of the demographic groups who are recruited and retained at each site. We will also collect information over the course of the trial on how often the translated PIL are used and whether people for whom these are used are recruited and retained. SWAT B - Sites who are willing to take part will evaluate whether an EDI-informed PIL increases the recruitment of underserved groups compared to the standard PIL. The exact content of the modified PIL is dependent on qualitative, diverse PPI work to be done during (around) the first year of the COMBAT study. Timeline The total study duration will be 48 months: Months 1-6: Set up activities. Months 7-15: Pilot Phase - Opening site, rec
1. Adults ≥50 years of age 2. Non-highly myopic (< -6 diopters; ≤26.5 mm axial length) phakic RRD 3. Naïve to previous vitreoretinal surgery 4. Pars plana vitrectomy is planned to repair their RRD
1. 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. 2. Pseudophakia or aphakia. 3. High myopia (≥ -6 diopters; >26.5 mm axial length). 4. Giant retinal tear (i.e. presence of one or more retinal tears of >3 clock hours in size) 5. Retinal dialysis 6. Inclusion in an investigational drug study 7. Declined consent for participation