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

NCT04723420 | Unknown DMC

• 1 other identifier: 270-2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Pneumatic Retinopexy; Steamroll; Direct to break

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Anatomical displacement of macula and its changes with time.

  1,2, 3 and 6 months post intervention

• Functional displacement of macula and its changes with time.

  1,2, 3 and 6 months post intervention

• Macular Status

  1hour, 2hours, Day 2, Week 1, Week 2

• Visual acuity

  1, 3 and 6 months post intervention

• Primary anatomical success

  1, 3 and 6 months post intervention

Study Arms (2)

Steamroller Technique

ACTIVE COMPARATOR

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

Direct Technique

ACTIVE COMPARATOR

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

Other: Direct technique

Interventions

Steamroller technique 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.

Steamroller Technique

Direct technique OTHER

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

Direct Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Interventions

Fluorescent Antibody Technique, Direct

Intervention Hierarchy (Ancestors)

Fluorescent Antibody Technique; Immunohistochemistry; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Kenneth Eng, MD FRCSC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: January 25, 2021
• Study Start: August 7, 2020
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CA (1)