Clinical trial NCT04723420: Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
Official title: Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhegmatogenous Retinal Detachment
Keywords: Pneumatic Retinopexy
Steamroll
Direct to break
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Macular status at Day 1
timeFrame: 24hours post intervention
Secondary outcomes:
measure: Anatomical displacement of macula and its changes with time.
timeFrame: 1,2, 3 and 6 months post intervention
measure: Functional displacement of macula and its changes with time.
timeFrame: 1,2, 3 and 6 months post intervention
measure: Macular Status
timeFrame: 1hour, 2hours, Day 2, Week 1, Week 2
measure: Visual acuity
timeFrame: 1, 3 and 6 months post intervention
measure: Primary anatomical success
timeFrame: 1, 3 and 6 months post intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Kenneth Eng, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References: