Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

September 3, 2019 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Abnormal surface autofluorescence
Time Frame: Up to 6 months after the operation
Up to 6 months after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 6, 2013

Primary Completion (ACTUAL)

April 24, 2015

Study Completion (ACTUAL)

April 24, 2015

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (ESTIMATE)

March 11, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISAICO-MUSELIER AOI 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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