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Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Epiretinal Membrane

Primary Purpose

Epiretinal Membrane

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Epiretinal Membrane Surgical treatment
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epiretinal Membrane focused on measuring Microperimetry, OCT, idiopathic epiretinal membrane

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Epiretinal Membrane

Exclusion Criteria:

  • Age related macular degeneration
  • Diabetic macular edema

Sites / Locations

  • Ophthalmology Department CHU Dijon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Epiretinal Membrane

Control

Arm Description

The investigators prospectively included 49 eyes of 49 patients with idiopathic ERM for which surgical treatment had been planned.

Subjects with normal visual acuity and OCT profile

Outcomes

Primary Outcome Measures

Macular sensitivity
The objective of this study was to assess macular function by measuring its sensitivity using microperimetry in patients with idiopathic ERM every three months up to one year. We compared the results of macular sensitivity to the best-corrected visual acuity (BCVA) and the OCT data to better understand the structure-function relationship.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2011
Last Updated
November 29, 2011
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01481987
Brief Title
Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Epiretinal Membrane
Official Title
Retinal Sensitivity and Optical Coherence Tomography Findings in Eyes With Idiopathic Epiretinal Membrane
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose: To evaluate macular sensitivity and its correlation with visual acuity and Spectral Domain Optical Coherence Tomography (SD-OCT) in eyes with idiopathic epiretinal membrane (ERM). Design: Cross sectional case-control series. Methods: Setting: Dijon University Hospital. Patients: Forty nine patients (49 eyes) with idiopathic ERM and twenty-seven healthy patients (27 eyes) as a control group. Main outcome measurement: Microperimetry, Spectral Domain Optical Coherence Tomography (SD-OCT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
Keywords
Microperimetry, OCT, idiopathic epiretinal membrane

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epiretinal Membrane
Arm Type
Experimental
Arm Description
The investigators prospectively included 49 eyes of 49 patients with idiopathic ERM for which surgical treatment had been planned.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects with normal visual acuity and OCT profile
Intervention Type
Procedure
Intervention Name(s)
Epiretinal Membrane Surgical treatment
Intervention Description
epiretinal membrane peeling
Primary Outcome Measure Information:
Title
Macular sensitivity
Description
The objective of this study was to assess macular function by measuring its sensitivity using microperimetry in patients with idiopathic ERM every three months up to one year. We compared the results of macular sensitivity to the best-corrected visual acuity (BCVA) and the OCT data to better understand the structure-function relationship.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Epiretinal Membrane Exclusion Criteria: Age related macular degeneration Diabetic macular edema
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Creuzot-Garcher, MD, PhD
Organizational Affiliation
CHU Dijon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology Department CHU Dijon
City
Dijon
State/Province
Burgundy
ZIP/Postal Code
21000
Country
France

12. IPD Sharing Statement

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Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Epiretinal Membrane

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