DOREFA (Retinal Detachment: Function and Anatomy) (DOREFA)

December 26, 2018 updated by: Centre Hospitalier Universitaire Dijon

Study of Anatomical and Functional Recovery Following Retinal Detachment: Identify Correlations Between Visual Acuity and SD-OCT and Microperimetry Findings.

Patients with retinal detachment do not always recover good visual function. Sometimes simple causes are responsible. Other causes can only be discovered thanks to high-resolution imaging provided by the latest generation of OCT.

This study is possible thanks to surgical teams who have a strong recruitment potential, with the experience of a joint project in 2007-2008 (PHRC national - Etude DOREMY, Etude FRIENDS) to define more strict intervention criteria. The principal objective of this study is to better define with regard to time:

  • The onset of surgically curable or transient macular affections, and losses in visual acuity that can be qualified as "explained"
  • But above all to better understand the relationships between anatomical analyses obtained using OCT and autofluorescence and functional analysis using visual acuity and microperimetry.
  • In the near future, two techniques (OCT and microperimetry) will certainly become essential tools in the evaluation of macular function. Better understanding of these relationships is the first necessary step in any study concerning the therapeutic prevention of retinal lesions related to retinal detachment: This study will make it possible to define criteria for the evaluation of anatomical and functional recovery, their relationship with each other and finally their evolution over time. This is an essential first phase before possible therapies can be evaluated.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Besançon, France, 25030
        • CHU Besançon
      • Bordeaux, France, 33000
        • CHU Bordeaux
      • Dijon, France, 21000
        • CHU Dijon
      • Grenoble, France, 38043
        • CHU Grenoble
      • Nancy, France, 54035
        • Chu Nancy
      • Nantes, France, 44093
        • CHU Nantes
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Reims, France, 51092
        • CHU Reims - Hôpital Robert Debré
      • Strasbourg, France, 67091
        • CHU Strasbourg - Hôpital Civil

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have provided written informed consent
  • Retinal detachment with pre-operative raised macula, re-attached during a surgical intervention with one month of follow-up
  • Patients undergoing surgery as the first-line treatment (ab extern surgery or gas vitrectomy)
  • Patients who accept to be followed for at least 12 months at the investigating center.

Exclusion Criteria:

  • Persons who are not registered with social security agency
  • Macular affections pre-existent to the DR
  • Retinal detachment requiring several interventions to obtain a reapplication
  • Lazy eye with pre-operative
  • Brightness of the circles not allowing the realization of the examinations

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between functional recovery and the aspect of external layers using Spectral Domain OCT.
Time Frame: At six months after the intervention
Visual acuity, integrity of the IS/OS junction of the photoreceptors and the outer limiting membrane.
At six months after the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Peripheral deficits and quantification of hypoautofluorescent zones.
Time Frame: At 3, 6 and 12 months after intervention
At 3, 6 and 12 months after intervention

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 (Actual)

November 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Actual)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 26, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Creuzot-Garcher PHRC N 2010

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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