Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02084212
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 25.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane Surgery	Other: Microperimetry	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Official Title: Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery
• Actual Study Start Date: Mar 6, 2013
• Actual Primary Completion Date: Apr 24, 2015
• Actual Study Completion Date: Apr 24, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients about to undergo epiretinal membrane surgery	Other: Microperimetry

Outcome Measures

Primary Outcome Measures

1. Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale [Up to 6 months after the operation.]

2. Anomalies observed in the outer layers of retina [Up to 6 months after the operation]

3. Evaluation of retinal sensitivity by microperimetry [Up to 6 months after the operation]

Secondary Outcome Measures

1. Abnormal surface autofluorescence [Up to 6 months after the operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de DIJON	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT02084212
• Other Study ID Numbers: ISAICO-MUSELIER AOI 2011
• First Posted: Mar 11, 2014
• Last Update Posted: Sep 4, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Epiretinal Membrane

Study Results

No Results Posted as of Sep 4, 2019