Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

Not Applicable

Terminated

• Conditions: Epiretinal Membrane Surgery
• Interventions: Other: Microperimetry

• Registration Number: NCT02084212
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data.

The examinations performed are those usually done in the follow-up of epiretinal membrane surgery, apart from microperimetry which is an examination of the central visual field. Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months and 6 months after the surgery. The consultation includes an assessment of visual acuity, a fundus examination an SD-OCT of the retina. The present protocol will require no additional visits. The microperimetry will be done in addition to the usual follow-up examinations after ERM surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-06
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-11
• Primary Completion: 2015-04-24
• Study Completion: 2015-04-24
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Persons who have provided consent,
• Patients about to undergo idiopathic epiretinal membrane surgery,
• Patients undergoing first-line macular surgery

Exclusion Criteria

• Persons not covered by national health insurance
• Preexisting disease of macula/epiretinal membrane (ARMD, chorioretinal scarring)
• Preoperative amblyopic eye
• Insufficiently transparent media making it impossible to do the examinations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients about to undergo epiretinal membrane surgery	Microperimetry	-

Primary Outcome Measures

Name	Time	Method
Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale	Up to 6 months after the operation.
Evaluation of retinal sensitivity by microperimetry	Up to 6 months after the operation
Anomalies observed in the outer layers of retina	Up to 6 months after the operation

Secondary Outcome Measures

Name	Time	Method
Abnormal surface autofluorescence	Up to 6 months after the operation

Trial Locations

Locations (1)

CHU de DIJON; 🇫🇷 Dijon, France