DOREFA (Retinal Detachment: Function and Anatomy)

Not Applicable

Completed

• Conditions: Retinal Detachment

• Registration Number: NCT01767038
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2018-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Peripheral deficits and quantification of hypoautofluorescent zones.	At 3, 6 and 12 months after intervention

Trial Locations

Locations (10)

CHU Reims - Hôpital Robert Debré; 🇫🇷 Reims, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France

CHU Besançon; 🇫🇷 Besançon, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU Strasbourg - Hôpital Civil; 🇫🇷 Strasbourg, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHU Nancy; 🇫🇷 Nancy, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Dijon; 🇫🇷 Dijon, France