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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
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Epiretinal Membrane Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 5, 2014
Last Updated
September 3, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
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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

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Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

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