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

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).

Study Overview

• Status: Recruiting
• Conditions: Rhegmatogenous Retinal Detachment
• Intervention / Treatment: Other: Steamroller technique; Other: Direct technique

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 416-480-5091; Email: Cindy.Rutz@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • SunnyBrook Health Sciences Centre
      • Contact: Kenneth Eng, MD FRCSC; Phone Number: 416-480-4688; Email: kenneth.eng@sunnybrook.ca
      • Principal Investigator: Kenneth Eng, MD FRCSC
      • Sub-Investigator: Peter Kertes, MD FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.	Other: Direct technique; Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular status at Day 1	Assessment of macular status by optical coherence tomography at 24 hours after intervention to see which technique is most effective for reattaching the macula	24hours post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical displacement of macula and its changes with time.	Measurement of retinal vessel imprinting on fundus autofluorescence	1,2, 3 and 6 months post intervention
Functional displacement of macula and its changes with time.	Measurement of metamorphopsia with M-charts	1,2, 3 and 6 months post intervention
Macular Status	Looking at macula status via optical coherence tomography after intervention to see which technique is more effective in reattaching the macula early	1hour, 2hours, Day 2, Week 1, Week 2
Visual acuity	ETDRS	1, 3 and 6 months post intervention
Primary anatomical success	Complete reattachment of retina via clinical fundus examination and optos fundus photography	1, 3 and 6 months post intervention

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Kenneth Eng, MD FRCSC, SunnyBrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Anticipated): December 7, 2023
• Study Completion (Anticipated): December 7, 2023

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pneumatic Retinopexy; Steamroll; Direct to break
• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Diseases; Retinal Detachment; Dissociative Disorders
• Other Study ID Numbers: 270-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No