Rhegmatogenous retinal detachment Eye Diseases
Conditions
Interventions
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 (includ
Sponsors
Queen's University Belfast
Eligibility
Sex/Gender
All
Age
50 Years to 150 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Best-Corrected Visual Acuity (BCVA) in the study eye from baseline to 52 weeks (+/- 6 weeks) after surgery (equivalence margin +/- 7 ETDRS letters). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Primary anatomical success is measured using retinal attachment status at 52 weeks (+/- 6 weeks) after one vitrectomy 2. Final anatomical success is measured using retinal attachment status at 52 weeks (+/- 6 weeks) after two or more vitrectomies 3. Intraoperative complications are measured using severity score during surgery 4. Postoperative complications are measured using severity score at 52 weeks (+/- 6 weeks) after surgery 5. Number and type of surgeries performed are measured using surgical records at 52 weeks (+/- 6 weeks) after surgery 6. Refractive error is measured using the difference between aimed and obtained post-operative refraction at 12 weeks after surgery in the phaco-vitrectomy arm and 6-8 weeks post-cataract surgery in the vitrectomy only arm 7. Proportion of participants with BCVA <69 letters is measured using BCVA test at 52 weeks (+/- 6 weeks) after surgery 8. Proportion of participants with BCVA <34 letters is measured using BCVA test at 52 weeks (+/- 6 weeks) after surgery 9. Time to achieve ‘best vision’ is measured using BCVA test at baseline and 52 weeks (+/- 6 weeks) after surgery 10. Change in BCVA from baseline over time is measured using BCVA test at baseline and 52 weeks (+/- 6 weeks) after surgery 11. Health-related quality of life is measured using EuroQol-5 level (EQ-5D-5L) at baseline and 52 weeks (+/- 6 weeks) after surgery 12. Vision-specific quality of life is measured using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at baseline and 52 weeks (+/- 6 weeks) after surgery 13. Participant’s experience and acceptability of treatments are measured using questionnaires at 52 weeks (+/- 6 weeks) after surgery 14. Use of health and social care services and non-health care is measured using questionnaires at 52 weeks (+/- 6 weeks) after surgery 15. Safety is measured using AE/SAE reporting at 52 weeks (+/- 6 weeks) after surgery | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Contacts
Public ContactColette Jackson
Outcome results
None listed