Trials / Unknown
UnknownNCT04723420
Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Sunnybrook Health Sciences Centre · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
| OTHER | Direct technique | Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break. |
Timeline
- Start date
- 2020-08-07
- Primary completion
- 2023-12-07
- Completion
- 2023-12-07
- First posted
- 2021-01-25
- Last updated
- 2023-04-13
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04723420. Inclusion in this directory is not an endorsement.