An interventional study of Steamroller technique and Direct technique in Rhegmatogenous Retinal Detachment, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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).
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.
207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 136 interventional studies indexed under Retinal Detachment.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
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.
Other: Steamroller technique
Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.
Other: Direct 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.
Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.
Macular status at Day 1
Assessment of macular status by optical coherence tomography at 24 hours after intervention to see which technique is most effective for reattaching the macula
Time frame: 24hours post intervention
Anatomical displacement of macula and its changes with time.
Measurement of retinal vessel imprinting on fundus autofluorescence
Time frame: 1,2, 3 and 6 months post intervention
Functional displacement of macula and its changes with time.
Measurement of metamorphopsia with M-charts
Time frame: 1,2, 3 and 6 months post intervention
Macular Status
Looking at macula status via optical coherence tomography after intervention to see which technique is more effective in reattaching the macula early
Time frame: 1hour, 2hours, Day 2, Week 1, Week 2
Visual acuity
ETDRS
Time frame: 1, 3 and 6 months post intervention
Primary anatomical success
Complete reattachment of retina via clinical fundus examination and optos fundus photography
Time frame: 1, 3 and 6 months post intervention
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre