Clinical trial NCT01767038: DOREFA (Retinal Detachment: Function and Anatomy)
Official title: Study of Anatomical and Functional Recovery Following Retinal Detachment: Identify Correlations Between Visual Acuity and SD-OCT and Microperimetry Findings.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Relationship between functional recovery and the aspect of external layers using Spectral Domain OCT.
timeFrame: At six months after the intervention
Secondary outcomes:
measure: Peripheral deficits and quantification of hypoautofluorescent zones.
timeFrame: At 3, 6 and 12 months after intervention
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Grenoble
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Reims
country: France
facility: CHU Reims - Hôpital Robert Debré
city: Strasbourg
country: France
facility: CHU Strasbourg - Hôpital Civil
Study officials:
References: