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

NCT ID: NCT02030262

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Epiretinal Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Air

The participant will undergo epiretinal membrane peeling with fluid-air exchange. The remaining of the surgery is the same in all arms.

Group Type EXPERIMENTAL

Epiretinal membrane peeling with fluid-air exchange

Intervention Type PROCEDURE

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.

Sulfur hexafluoride (SF6)

The participant will undergo epiretinal membrane peeling with fluid-SF6 exchange. The remaining of the surgery will stay the same.

Group Type ACTIVE_COMPARATOR

Epiretinal membrane peeling with fluid-SF6 exchange

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu Caissie, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du CHU de Québec; Université Laval

Locations

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Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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C13-10-1231

Identifier Type: -

Identifier Source: org_study_id

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