Retinal Displacement After Pneumatic Versus Vitrectomy for Retinal Detachment (ALIGN)

CompletedOBSERVATIONAL
Enrollment

204

Participants

Timeline

Start Date

June 27, 2018

Primary Completion Date

March 31, 2021

Study Completion Date

March 31, 2021

Conditions
Retinal DetachmentMetamorphopsiaAniseikonia
Interventions
PROCEDURE

Pneumatic Retinopexy

The PnR technique is performed as per the PIVOT trial under local anaesthetic. First, patients will undergo a thorough scleral-depressed peripheral retinal examination to identify all pathologic features. Second, laser retinopexy will be applied to all breaks, lattice degeneration, or both in the attached retina before gas injection. Third, breaks in the detached retina will be treated with cryotherapy before gas injection or (preferably) laser retinopexy 24 to 48 hours after gas injection, with additional laser retinopexy applied at any point per surgeon discretion. Finally, anterior chamber paracentesis will be used to express as much fluid as safely possible (generally 0.3ml), followed by intravitreal injection of 100% SF6 (ideally 0.6 ml). Patients will be positioned face down for 6 hours and then raise their head 30 degrees every hour (steam roll) and then positioned to the responsible break.

PROCEDURE

Pars Plana Vitrectomy

For PPV, a standard 3-port PPV (23 or 25-gauge) will be performed, including posterior hyaloid detachment, core vitrectomy and 360 peripheral vitreous shave. Subretinal fluid will be drained either through the peripheral break or through a posterior retinotomy with use of heavy liquid to assist with appropriate drainage at the discretion of the responsible surgeon. A complete air-fluid exchange will be performed. Endolaser Retinopexy or transconjunctival cryopexy will be performed to treat any retinal pathology, including lattice degeneration and breaks in the attached and detached retina. A iso-expansible concentration of SF6 or C3F8 gas will be injected at the completion of the surgery. Choice of gas will be at the discretion of the responsible surgeon. Patients will be positioned immediately face down for the first 24 hours and then according to the position of the responsible break.

Trial Locations (1)

M5C 2T2

Department of Ophthalmology, St Michael's Hospital, Toronto

All Listed Sponsors
lead

Unity Health Toronto

OTHER

NCT04089033 - Retinal Displacement After Pneumatic Versus Vitrectomy for Retinal Detachment (ALIGN) | Biotech Hunter | Biotech Hunter