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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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01767038
Acronym
DOREFA
Enrollment
202
Registered
2013-01-11
Start date
2011-11-01
Completion date
2015-05-01
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

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.

Interventions

PROCEDUREOCT Spectralis

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relationship between functional recovery and the aspect of external layers using Spectral Domain OCT.At six months after the interventionVisual acuity, integrity of the IS/OS junction of the photoreceptors and the outer limiting membrane.

Secondary

MeasureTime frame
Peripheral deficits and quantification of hypoautofluorescent zones.At 3, 6 and 12 months after intervention

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026