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

Primary Purpose

Rhegmatogenous Retinal Detachment

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Steamroller technique
Direct technique
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring Pneumatic Retinopexy, Steamroll, Direct to break

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Steamroller Technique

Direct Technique

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Anatomical displacement of macula and its changes with time.
Measurement of retinal vessel imprinting on fundus autofluorescence
Functional displacement of macula and its changes with time.
Measurement of metamorphopsia with M-charts
Macular Status
Looking at macula status via optical coherence tomography after intervention to see which technique is more effective in reattaching the macula early
Visual acuity
ETDRS
Primary anatomical success
Complete reattachment of retina via clinical fundus examination and optos fundus photography

Full Information

First Posted
December 19, 2020
Last Updated
April 11, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04723420
Brief Title
Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
Official Title
Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
December 7, 2023 (Anticipated)
Study Completion Date
December 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Retinal Detachment
Keywords
Pneumatic Retinopexy, Steamroll, Direct to break

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Steamroller Technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Direct Technique
Arm Type
Active Comparator
Arm Description
Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.
Intervention Type
Other
Intervention Name(s)
Steamroller technique
Intervention Description
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
Intervention Name(s)
Direct technique
Intervention Description
Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.
Primary Outcome Measure Information:
Title
Macular status at Day 1
Description
Assessment of macular status by optical coherence tomography at 24 hours after intervention to see which technique is most effective for reattaching the macula
Time Frame
24hours post intervention
Secondary Outcome Measure Information:
Title
Anatomical displacement of macula and its changes with time.
Description
Measurement of retinal vessel imprinting on fundus autofluorescence
Time Frame
1,2, 3 and 6 months post intervention
Title
Functional displacement of macula and its changes with time.
Description
Measurement of metamorphopsia with M-charts
Time Frame
1,2, 3 and 6 months post intervention
Title
Macular Status
Description
Looking at macula status via optical coherence tomography after intervention to see which technique is more effective in reattaching the macula early
Time Frame
1hour, 2hours, Day 2, Week 1, Week 2
Title
Visual acuity
Description
ETDRS
Time Frame
1, 3 and 6 months post intervention
Title
Primary anatomical success
Description
Complete reattachment of retina via clinical fundus examination and optos fundus photography
Time Frame
1, 3 and 6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
416-480-5091
Email
Cindy.Rutz@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Eng, MD FRCSC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Eng, MD FRCSC
Phone
416-480-4688
Email
kenneth.eng@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Kenneth Eng, MD FRCSC
First Name & Middle Initial & Last Name & Degree
Peter Kertes, MD FRCSC

12. IPD Sharing Statement

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

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