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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01481987
First Posted: November 30, 2011
Last Update Posted: November 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nicot Frederic, Centre Hospitalier Universitaire Dijon
  Purpose

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).


Condition Intervention
Epiretinal Membrane Procedure: Epiretinal Membrane Surgical treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Retinal Sensitivity and Optical Coherence Tomography Findings in Eyes With Idiopathic Epiretinal Membrane

Resource links provided by NLM:


Further study details as provided by Nicot Frederic, Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Macular sensitivity [ Time Frame: 12 months ]
    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.


Enrollment: 76
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epiretinal Membrane
The investigators prospectively included 49 eyes of 49 patients with idiopathic ERM for which surgical treatment had been planned.
Procedure: Epiretinal Membrane Surgical treatment
epiretinal membrane peeling
No Intervention: Control
Subjects with normal visual acuity and OCT profile

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Epiretinal Membrane

Exclusion Criteria:

  • Age related macular degeneration
  • Diabetic macular edema
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481987


Locations
France
Ophthalmology Department CHU Dijon
Dijon, Burgundy, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
Principal Investigator: Catherine Creuzot-Garcher, MD, PhD CHU Dijon
  More Information

Responsible Party: Nicot Frederic, Head of research unit in Ophthalmology department, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01481987     History of Changes
Other Study ID Numbers: Rodica 01
First Submitted: November 21, 2011
First Posted: November 30, 2011
Last Update Posted: November 30, 2011
Last Verified: November 2011

Keywords provided by Nicot Frederic, Centre Hospitalier Universitaire Dijon:
Microperimetry
OCT
idiopathic epiretinal membrane

Additional relevant MeSH terms:
Epiretinal Membrane
Retinal Diseases
Eye Diseases