Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not

Sunnybrook Health Sciences Centre

Status: Enrolling

Conditions: Rhegmatogenous Retinal Detachment

Treatments: Other: Direct technique; Other: Steamroller technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04723420

270-2019

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Steamroller Technique

Active Comparator group

Description:

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.

Treatment:

Other: Steamroller technique

Direct Technique

Active Comparator group

Description:

Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.

Treatment:

Other: Direct technique