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

NCT ID: NCT04723420

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-07
• Study Completion Date: 2023-12-07

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.

Conditions

Rhegmatogenous Retinal Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Steamroller technique

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Direct technique

Intervention Type: OTHER

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.

Intervention Type: OTHER

Direct technique

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kenneth Eng

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Eng, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Study Coordinator

Role: CONTACT

Cindy.Rutz@sunnybrook.ca

416-480-5091

Facility Contacts

Kenneth Eng, MD FRCSC

Role: primary

kenneth.eng@sunnybrook.ca

416-480-4688

Other Identifiers

270-2019

Identifier Type: -

Identifier Source: org_study_id