Study of Impact of Air vs SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
Study of the Impact of Air Versus SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 7, 2014
CompletedFirst Posted
Study publicly available on registry
January 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 8, 2016
March 1, 2016
2 years
January 7, 2014
March 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity
6 months
Study Arms (2)
Air
EXPERIMENTALThe participant will undergo epiretinal membrane peeling with fluid-air exchange. The remaining of the surgery is the same in all arms.
Sulfur hexafluoride (SF6)
ACTIVE COMPARATORThe participant will undergo epiretinal membrane peeling with fluid-SF6 exchange. The remaining of the surgery will stay the same.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of epiretinal membrane with corresponding optical coherence tomography
- ETDRS visual acuity worse or equal to 20/30
- Adult able to give consent
You may not qualify if:
- Diagnosis of age-related macular degeneration
- Opacity blocking the fundus visualisation
- Presence of active intraocular inflammation
- Presence of intraocular tumor
- Presence of retinal detachment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, Quebec, G1S 4L8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathieu Caissie, MD, FRCSC
Centre de recherche du CHU de Québec; Université Laval
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2014
First Posted
January 8, 2014
Study Start
December 1, 2013
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
March 8, 2016
Record last verified: 2016-03