NCT01481987

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

November 21, 2011

Last Update Submit

November 29, 2011

Conditions

Epiretinal Membrane

Keywords

MicroperimetryOCTidiopathic epiretinal membrane

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Epiretinal Membrane

EXPERIMENTAL

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

Procedure: Epiretinal Membrane Surgical treatment

Control

NO INTERVENTION

Subjects with normal visual acuity and OCT profile

Interventions

Epiretinal Membrane Surgical treatmentPROCEDURE

epiretinal membrane peeling

Epiretinal Membrane

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Epiretinal Membrane

You may not qualify if:

  • Age related macular degeneration
  • Diabetic macular edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Department CHU Dijon

Dijon, Burgundy, 21000, France

Location

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Catherine Creuzot-Garcher, MD, PhD

    CHU Dijon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research unit in Ophthalmology department

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 30, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

FR(1)