DOREFA (Retinal Detachment: Function and Anatomy)

Retinal Detachment Clinical Trial

— DOREFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767038
• Other study ID #: Creuzot-Garcher PHRC N 2010
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: May 2015

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

Procedure:
• OCT Spectralis

• microperimetry

Locations

Country	Name	City	State
France	CHU Besançon	Besançon
France	CHU Bordeaux	Bordeaux
France	CHU Dijon	Dijon
France	CHU Grenoble	Grenoble
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Hôpital Lariboisière	Paris
France	CHU Reims - Hôpital Robert Debré	Reims
France	CHU Strasbourg - Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between functional recovery and the aspect of external layers using Spectral Domain OCT.	Visual acuity, integrity of the IS/OS junction of the photoreceptors and the outer limiting membrane.	At six months after the intervention
Secondary	Peripheral deficits and quantification of hypoautofluorescent zones.		At 3, 6 and 12 months after intervention