NCT01767038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

January 10, 2013

Last Update Submit

February 5, 2026

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Peripheral deficits and quantification of hypoautofluorescent zones.

    At 3, 6 and 12 months after intervention

Interventions

OCT SpectralisPROCEDURE
microperimetryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Besançon

Besançon, 25030, France

Location

CHU Bordeaux

Bordeaux, 33000, France

Location

CHU Dijon

Dijon, 21000, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CHU Nancy

Nancy, 54035, France

Location

CHU Nantes

Nantes, 44093, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

CHU Reims - Hôpital Robert Debré

Reims, 51092, France

Location

CHU Strasbourg - Hôpital Civil

Strasbourg, 67091, France

Location

Related Publications (1)

  • 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.

    PMID: 33576133RESULT

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 11, 2013

Study Start

November 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

FR(10)