DOREFA (Retinal Detachment: Function and Anatomy)

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire Dijon

Source 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.

Overall Status Completed
Start Date November 2011
Completion Date May 2015
Primary Completion Date May 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Relationship between functional recovery and the aspect of external layers using Spectral Domain OCT. At six months after the intervention
Secondary Outcome
Measure Time Frame
Peripheral deficits and quantification of hypoautofluorescent zones. At 3, 6 and 12 months after intervention
Enrollment 202
Condition
Intervention

Intervention Type: Procedure

Intervention Name: OCT Spectralis

Intervention Type: Procedure

Intervention Name: microperimetry

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
CHU Besançon | Besançon, 25030, France
CHU Bordeaux | Bordeaux, 33000, France
CHU Dijon | Dijon, 21000, France
CHU Grenoble | Grenoble, 38043, France
CHU Nancy | Nancy, 54035, France
CHU Nantes | Nantes, 44093, France
Hôpital Lariboisière | Paris, 75010, France
Fondation Ophtalmologique Adolphe de Rothschild | Paris, 75019, France
CHU Reims - Hôpital Robert Debré | Reims, 51092, France
CHU Strasbourg - Hôpital Civil | Strasbourg, 67091, France
Location Countries

France

Verification Date

December 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Acronym DOREFA
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov