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

Laval University

Status: Completed

Conditions: Epiretinal Membrane

Treatments: Procedure: Epiretinal membrane peeling with fluid-air exchange; Procedure: Epiretinal membrane peeling with fluid-SF6 exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT02030262

C13-10-1231

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

Air

Experimental group

Description:

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

Treatment:

Procedure: Epiretinal membrane peeling with fluid-air exchange

Sulfur hexafluoride (SF6)

Active Comparator group

Description:

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

Treatment:

Procedure: Epiretinal membrane peeling with fluid-SF6 exchange