Study of Impact of Air vs SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping

Epiretinal Membrane Clinical Trial

Official title:

Study of the Impact of Air Versus SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030262
• Other study ID #: C13-10-1231
• Status: Completed
• Phase: N/A
• First received: January 7, 2014
• Last updated: March 4, 2016
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Procedure:
• Epiretinal membrane peeling with fluid-air exchange
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.
• Epiretinal membrane peeling with fluid-SF6 exchange
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.

Locations

Country	Name	City	State
Canada	Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity		6 months	No