Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
- Conditions
- Rhegmatogenous Retinal Detachment
- Interventions
- Other: Direct techniqueOther: Steamroller technique
- Registration Number
- NCT04723420
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Brief Summary
This is a randomized controlled trial comparing displacement of macula and the rapidity of reattachment of macula between two different positioning techniques after pneumatic retinopexy : Direct technique (patient is positioned so that the bubble is immediately placed directly over the retina break) and Steamroller technique (patient is initially positioned face down for 4-6 hours and subsequently changes their head position so that the bubble is then placed directly over the retina break).
- Detailed Description
Pneumatic retinopexy (PR) is an established treatment for rhegmatogenous retinal detachment (RRD). In our centre, PR is the most commonly performed procedure for primary RRD repair with a high retinal reattachment success rate. In this procedure, patients are required to position according to the site of pathology following injection of an intravitreal gas bubble. Some practitioners position the patient so that the gas bubble is immediately apposed directly against the retinal break (direct technique). Others favour the steamroller technique whereby the patient is initially positioned face down, then after 4-6 hours, the position is changed sequentially so that the bubble is rolled over the retina towards the break responsible for the detachment (steamroller technique). Variable visual acuity (VA) outcomes and metamorphopsia are common post-procedure complaints despite successful RRD repair with PR. It has been suggested that variability in functional outcomes may be associated with the timing and ease of reattachment of macula. The purpose of this prospective study is to evaluate whether the steamroller technique is superior to the direct technique in faster reattachment of macula with less macula displacement.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Primary RRD
- Causative breaks over superior 8 clock hours
- Single break or group of breaks
- No or min proliferative vitreoretinopathy (PVR) (Grade A or B)
- Other breaks or lattice in attached retina are allowed
- Retinal break in the inferior 4 clock hours in detached retina
- PVR Grade C or worse
- Significant media opacity (Vitreous hemorrhage, dense cataract, cornea scar, etc)
- Pre-existing ocular pathology [macula hole (MH), epiretinal membrane (ERM), cystoid macula edema (CME), age-related macula degeneration, myopic degeneration, advanced glaucoma, uveitis, amblyopia etc] or previous eye trauma with poor baseline vision
- Previous pars plana vitrectomy
- Age ≤18years old
- Inadequate physical or mental competence to maintain the required postoperative head position
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Direct Technique Direct technique Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break. Steamroller Technique Steamroller technique Following intravitreal gas injection, patient positioned face down for 4-6 hours and subsequently patient changes the position of the head so that the bubble is then placed directly over the retina break.
- Primary Outcome Measures
Name Time Method Macular status at Day 1 24hours post intervention Assessment of macular status by optical coherence tomography at 24 hours after intervention to see which technique is most effective for reattaching the macula
- Secondary Outcome Measures
Name Time Method Anatomical displacement of macula and its changes with time. 1,2, 3 and 6 months post intervention Measurement of retinal vessel imprinting on fundus autofluorescence
Functional displacement of macula and its changes with time. 1,2, 3 and 6 months post intervention Measurement of metamorphopsia with M-charts
Macular Status 1hour, 2hours, Day 2, Week 1, Week 2 Looking at macula status via optical coherence tomography after intervention to see which technique is more effective in reattaching the macula early
Visual acuity 1, 3 and 6 months post intervention ETDRS
Primary anatomical success 1, 3 and 6 months post intervention Complete reattachment of retina via clinical fundus examination and optos fundus photography
Trial Locations
- Locations (1)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada