Back to resultsStudy of Impact of Air vs SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
Primary Purpose
Epiretinal Membrane
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Epiretinal membrane peeling with fluid-air exchange
Epiretinal membrane peeling with fluid-SF6 exchange
Sponsored by
About this trial
This is an interventional treatment trial for Epiretinal Membrane
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of epiretinal membrane with corresponding optical coherence tomography
- ETDRS visual acuity worse or equal to 20/30
- Adult able to give consent
Exclusion Criteria:
- Diagnosis of age-related macular degeneration
- Opacity blocking the fundus visualisation
- Presence of active intraocular inflammation
- Presence of intraocular tumor
- Presence of retinal detachment
Sites / Locations
- Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Air
Sulfur hexafluoride (SF6)
Arm Description
The participant will undergo epiretinal membrane peeling with fluid-air exchange. The remaining of the surgery is the same in all arms.
The participant will undergo epiretinal membrane peeling with fluid-SF6 exchange. The remaining of the surgery will stay the same.
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT02030262
First Posted
January 7, 2014
Last Updated
March 4, 2016
Sponsor
CHU de Quebec-Universite Laval
1. Study Identification
Unique Protocol Identification Number
NCT02030262
Brief Title
Study of Impact of Air vs SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
Official Title
Study of the Impact of Air Versus SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride) is better than the other in epiretinal membrane peeling surgery. Both are already used for this surgery and this study will tell us if one is better than the other.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Air
Arm Type
Experimental
Arm Description
The participant will undergo epiretinal membrane peeling with fluid-air exchange. The remaining of the surgery is the same in all arms.
Arm Title
Sulfur hexafluoride (SF6)
Arm Type
Active Comparator
Arm Description
The participant will undergo epiretinal membrane peeling with fluid-SF6 exchange. The remaining of the surgery will stay the same.
Intervention Type
Procedure
Intervention Name(s)
Epiretinal membrane peeling with fluid-air exchange
Intervention Description
The intervention starts with a pars plana vitrectomy and then a epiretinal membrane peeling is performed. During the fluid-gaz exchange, the gaz used will be air. The remaining of the intervention is the same between the two arms.
Intervention Type
Procedure
Intervention Name(s)
Epiretinal membrane peeling with fluid-SF6 exchange
Intervention Description
The intervention starts with a pars plana vitrectomy and then a epiretinal membrane peeling is performed. During the fluid-gaz exchange, the gaz used will be SF6 (sulfur hexafluoride). The remaining of the intervention is the same between the two arms.
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of epiretinal membrane with corresponding optical coherence tomography
ETDRS visual acuity worse or equal to 20/30
Adult able to give consent
Exclusion Criteria:
Diagnosis of age-related macular degeneration
Opacity blocking the fundus visualisation
Presence of active intraocular inflammation
Presence of intraocular tumor
Presence of retinal detachment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Caissie, MD, FRCSC
Organizational Affiliation
Centre de recherche du CHU de Québec; Université Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of Impact of Air vs SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
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