- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01767038
DOREFA (Retinal Detachment: Function and Anatomy) (DOREFA)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
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
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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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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