DOREFA (Retinal Detachment: Function and Anatomy) | NCT01767038

Studies
DOREFA (Retinal Detachment: Function and Anatomy)

NCT01767038

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Feb 9, 2026Actual

Enrollment

202Actual

Phase

Not Applicable

Conditions

Retinal Detachment

Interventions

OCT Spectralis
microperimetry

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011Actual

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jan 10, 2013

First Submission Date that Met QC Criteria

Jan 10, 2013

First Posted Date

Jan 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

202Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Peripheral deficits and quantification of hypoautofluorescent zones.		At 3, 6 and 12 months after intervention

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besançon		Besançon		25030	France
CHU Bordeaux

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33576133	Result	Baudin F, Deschasse C, Gabrielle PH, Berrod JP, Le Mer Y, Arndt C, Tadayoni R, Delyfer MN, Weber M, Gaucher D, Saleh M, Chiquet C, Creuzot-Garcher C. Functional and anatomical outcomes after successful repair of macula-off retinal detachment: a 12-month follow-up of the DOREFA study. Acta Ophthalmol. 2021 Nov;99(7):e1190-e1197. doi: 10.1111/aos.14777. Epub 2021 Feb 11.

Name	Type	Description	Arm Group Labels	Other Names
OCT Spectralis	Procedure
microperimetry	Procedure

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases