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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02030262
Other study ID # C13-10-1231
Secondary ID
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


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
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