Prognostic Factors in Epiretinal Membrane Surgery

March 30, 2015 updated by: Centre Hospitalier Universitaire Dijon

Preoperative Prognostic Factors and Predictive Score in Patients Operated on for Combined Cataract and Idiopathic Epiretinal Membrane.

Retrospective interventional case series study reporting preoperative clinical and anatomical factors associated with visual recovery 1 year after combined cataract and idiopathic epiretinal membrane surgery. Age, duration of symptoms, and preoperative best corrected visual acuity appeared to be reliable prognostic factors. Combining these factors with analysis of the photoreceptors' inner and outer segments junction in spectral-domain optical coherence tomography provides a predictive score to estimate individual chances of good visual recovery

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients operated on for combined cataract and idiopathic epiretinal membrane

Description

Inclusion Criteria:

  • symptomatic idiopathic epiretinal membrane operated on between April 2009 and September 2012 at the university hospital of Dijon, France.
  • All patients signed informed consent for the surgical procedure.

Exclusion Criteria:

  • Patients were excluded if they presented any cause of secondary epiretinal membrane (including diabetic retinopathy, vein occlusion, ocular inflammation, retinal detachment, or previously vitrectomized eye), high myopia (axial length ≥ 26 mm or spherical equivalent ≥ 6 diopters), severe media opacities with weak SD-OCT signal strengths, or any macular or optic nerve disease. Patients with a follow-up of less than 12 months were excluded and only one eye was included in those with bilateral epiretinal membranes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity
Time Frame: 1 year after the surgery
Best corrected visual acuity 1 year after the surgery, and preoperative factors associated with this visual outcome (age, duration of symptoms, initial best corrected visual acuity, and optical coherence tomography findings)
1 year after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To set up a predictive score for a >= 20/20 best corrected visual acuity
Time Frame: 1 year after the surgery
To set up a predictive score for a >= 20/20 best corrected visual acuity, 1year after a combined cataract and epiretinal membrane surgery
1 year after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

April 2, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREUZOT 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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