A Randomised Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment; Anatomical Success, Functional Success and Impact on Patient Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Unity Health Toronto
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Visual acuity
Study Overview
Brief Summary
The purpose of this research study is to compare the outcomes of pneumatic retinopexy with the outcomes of vitrectomy (with or without scleral buckle) for the management of retinal detachment, in terms of anatomical success, functional success and impact on patient quality of life.
Detailed Description
Rhegmatogenous retinal detachment (RRD)is an acute, sight threatening condition, with an incidence of approximately 10 per 100,000 population. Both of the treatments under investigation are widely used and accepted by vitreoretinal surgeons, but randomised, prospective comparison of the two techniques has not been reported in the scientific literature to date. Currently, the management decisions surrounding primary retinal detachment are grounded on a weak evidence base. The findings of this study will allow vitreoretinal surgeons and their patients to select the most appropriate intervention for that individual, in an informed and holistic manner.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients presenting with acute rhegmatogenous retinal detachment
- •Single retinal break OR group of breaks no larger than one clock hour (30°)
- •All break/s in detached retina between 8-4 o'clock
- •No significant proliferative vitreoretinopathy
Exclusion Criteria
- •Inferior breaks in detached retina
- •Inability to read English language
- •Age < 18 years
- •Mental incapacity
- •Previous vitrectomy (index eye)
- •Previous retinal detachment (index eye)
- •Inability to maintain the post-operative posturing
- •Inability to carry out detailed examination of peripheral retina due to media opacity
Arms & Interventions
Vitrectomy
Intervention: Vitrectomy (Procedure)
Pneumatic retinopexy
Intervention: Pneumatic retinopexy (Procedure)
Outcomes
Primary Outcomes
Visual acuity
Time Frame: 12 months post intervention
Secondary Outcomes
- Visual acuity(1 week, 1 month, 3 months and 6 months post intervention)
- Subjective visual function(3, 6 and 12 months post intervention)
- Anatomical success (complete retinal re-attachment)(3, 6 and 12 months post intervention)
- Subjective health related quality of life(Baseline and 1 month post intervention)