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NCT Number: NCT01767038

DOREFA (Retinal Detachment: Function and Anatomy)

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.

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Besançon, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCT Spectralis

Procedure

microperimetry

Procedure

Primary outcomes

  1. Relationship between functional recovery and the aspect of external layers using Spectral Domain OCT.

    Time frame: At six months after the intervention

    Visual acuity, integrity of the IS/OS junction of the photoreceptors and the outer limiting membrane.

Secondary outcomes

  1. Peripheral deficits and quantification of hypoautofluorescent zones.

    Time frame: At 3, 6 and 12 months after intervention

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: DOREFA

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 11, 2013
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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