Recruiting

Pneumatic Retinopexy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04723420

Conditions

Rhegmatogenous Retinal Detachment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Steamroller technique

Direct technique

Study Details

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).

Conditions

Rhegmatogenous Retinal Detachment

Study ID

NCT04723420

Start date

Aug 7, 2020

Status verified date

Apr, 2023

Completion date

Dec 7, 2023

Anticipated

Primary completion date

Dec 7, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: Direct Technique

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

Interventions

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.

Direct technique

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

Primary outcome measure

  • Macular status at Day 1 [ Time Frame: 24hours post intervention ]

Central Contacts and Locations

Central contacts

Study Coordinator

416-480-5091Cindy.Rutz@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Kenneth Eng, MD FRCSC

416-480-4688kenneth.eng@sunnybrook.ca

Principal Investigator:

Kenneth Eng, MD FRCSC

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 13, 2023

Last verified

Apr, 2023

Keywords

  • Pneumatic Retinopexy
  • Steamroll
  • Direct to break

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-04-13.