Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery
Primary Purpose
Epiretinal Membrane Surgery
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Microperimetry
Sponsored by
About this trial
This is an interventional trial for Epiretinal Membrane Surgery
Eligibility Criteria
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
Sites / Locations
- CHU de DIJON
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients about to undergo epiretinal membrane surgery
Arm Description
Outcomes
Primary Outcome Measures
Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale
Anomalies observed in the outer layers of retina
Evaluation of retinal sensitivity by microperimetry
Secondary Outcome Measures
Abnormal surface autofluorescence
Full Information
NCT ID
NCT02084212
First Posted
March 5, 2014
Last Updated
September 3, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02084212
Brief Title
Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery
Official Title
Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Study Start Date
March 6, 2013 (Actual)
Primary Completion Date
April 24, 2015 (Actual)
Study Completion Date
April 24, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane Surgery
7. Study Design
Study Phase
Not Applicable
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients about to undergo epiretinal membrane surgery
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Microperimetry
Primary Outcome Measure Information:
Title
Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale
Time Frame
Up to 6 months after the operation.
Title
Anomalies observed in the outer layers of retina
Time Frame
Up to 6 months after the operation
Title
Evaluation of retinal sensitivity by microperimetry
Time Frame
Up to 6 months after the operation
Secondary Outcome Measure Information:
Title
Abnormal surface autofluorescence
Time Frame
Up to 6 months after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery
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