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

Overview

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.

Full Title of Study: “Study of the Impact of Air Versus SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2015

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Air
    • The participant will undergo epiretinal membrane peeling with fluid-air exchange. The remaining of the surgery is the same in all arms.
  • Active Comparator: Sulfur hexafluoride (SF6)
    • The participant will undergo epiretinal membrane peeling with fluid-SF6 exchange. The remaining of the surgery will stay the same.

Clinical Trial Outcome Measures

Primary Measures

  • Visual acuity
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CHU de Quebec-Universite Laval
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mathieu Caissie, MD, FRCSC, Principal Investigator, Centre de recherche du CHU de Québec; Université Laval

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