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

Epiretinal Membrane Clinical Trial

Official title:

Retinal Sensitivity and Optical Coherence Tomography Findings in Eyes With Idiopathic Epiretinal Membrane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481987
• Other study ID #: Rodica 01
• Status: Completed
• Phase: N/A
• First received: November 21, 2011
• Last updated: November 29, 2011
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Epiretinal Membrane

Exclusion Criteria:

• Age related macular degeneration

• Diabetic macular edema

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Procedure:
• Epiretinal Membrane Surgical treatment
epiretinal membrane peeling

Locations

Country	Name	City	State
France	Ophthalmology Department CHU Dijon	Dijon	Burgundy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No