DOREFA (Retinal Detachment: Function and Anatomy) (DOREFA)
Recruitment status was: Recruiting
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 Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Study of Anatomical and Functional Recovery Following Retinal Detachment: Identify Correlations Between Visual Acuity and SD-OCT and Microperimetry Findings.|
- 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.
- Peripheral deficits and quantification of hypoautofluorescent zones. [ Time Frame: At 3, 6 and 12 months after intervention ]
|Study Start Date:||November 2011|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767038
|Besançon, France, 25030|
|Bordeaux, France, 33000|
|Dijon, France, 21000|
|Grenoble, France, 38043|
|Nancy, France, 54035|
|Nantes, France, 44093|
|Paris, France, 75010|
|Fondation Ophtalmologique Adolphe de Rothschild|
|Paris, France, 75019|
|CHU Reims - Hôpital Robert Debré|
|Reims, France, 51092|
|CHU Strasbourg - Hôpital Civil|
|Strasbourg, France, 67091|