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

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ClinicalTrials.gov Identifier: NCT04723420
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Kenneth Eng, Sunnybrook Health Sciences Centre

Study Description
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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).

Condition or disease Intervention/treatment Phase
Rhegmatogenous Retinal Detachment Other: Steamroller technique Other: Direct technique Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : May 7, 2021
Estimated Study Completion Date : November 7, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Macular status at Day 1 [ Time Frame: 24hours post intervention ]
    Assessment of macular status by optical coherence tomography at 24 hours after intervention to see which technique is most effective for reattaching the macula


Secondary Outcome Measures :
  1. Anatomical displacement of macula and its changes with time. [ Time Frame: 1,2, 3 and 6 months post intervention ]
    Measurement of retinal vessel imprinting on fundus autofluorescence

  2. Functional displacement of macula and its changes with time. [ Time Frame: 1,2, 3 and 6 months post intervention ]
    Measurement of metamorphopsia with M-charts

  3. Macular Status [ Time Frame: 1hour, 2hours, Day 2, Week 1, Week 2 ]
    Looking at macula status via optical coherence tomography after intervention to see which technique is more effective in reattaching the macula early

  4. Visual acuity [ Time Frame: 1, 3 and 6 months post intervention ]
    ETDRS

  5. Primary anatomical success [ Time Frame: 1, 3 and 6 months post intervention ]
    Complete reattachment of retina via clinical fundus examination and optos fundus photography


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723420


Contacts
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Contact: Study Coordinator 416-480-5091 Cindy.Rutz@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Kenneth Eng, MD FRCSC    416-480-4688    kenneth.eng@sunnybrook.ca   
Principal Investigator: Kenneth Eng, MD FRCSC         
Sub-Investigator: Peter Kertes, MD FRCSC         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Kenneth Eng, MD FRCSC Sunnybrook Health Sciences Centre
More Information
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Responsible Party: Dr. Kenneth Eng, Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04723420    
Other Study ID Numbers: 270-2019
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Kenneth Eng, Sunnybrook Health Sciences Centre:
Pneumatic Retinopexy
Steamroll
Direct to break
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases