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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicot Frederic, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01481987
First received: November 21, 2011
Last updated: November 29, 2011
Last verified: November 2011
  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: Open Label
Primary Purpose: Basic Science
Official Title: Retinal Sensitivity and Optical Coherence Tomography Findings in Eyes With Idiopathic Epiretinal Membrane

Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Macular sensitivity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Epiretinal Membrane

Exclusion Criteria:

  • Age related macular degeneration
  • Diabetic macular edema
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 21, 2011
Last Updated: November 29, 2011
Health Authority: France: Direction Générale de la Santé

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

Additional relevant MeSH terms:
Epiretinal Membrane
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014