Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

DOREFA (Retinal Detachment: Function and Anatomy) (DOREFA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01767038
First received: January 10, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.

Condition Intervention
Retinal Detachment
Procedure: OCT Spectralis
Procedure: microperimetry

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study of Anatomical and Functional Recovery Following Retinal Detachment: Identify Correlations Between Visual Acuity and SD-OCT and Microperimetry Findings.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Peripheral deficits and quantification of hypoautofluorescent zones. [ Time Frame: At 3, 6 and 12 months after intervention ]

Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767038

Locations
France
CHU Besançon
Besançon, France, 25030
CHU Bordeaux
Bordeaux, France, 33000
CHU Dijon
Dijon, France, 21000
CHU Grenoble
Grenoble, France, 38043
CHU Nancy
Nancy, France, 54035
CHU Nantes
Nantes, France, 44093
Hôpital Lariboisière
Paris, France, 75010
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France, 75019
CHU Reims - Hôpital Robert Debré
Reims, France, 51092
CHU Strasbourg - Hôpital Civil
Strasbourg, France, 67091
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01767038     History of Changes
Other Study ID Numbers: Creuzot-Garcher PHRC N 2010 
Study First Received: January 10, 2013
Last Updated: January 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dissociative Disorders
Retinal Detachment
Mental Disorders
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on December 02, 2016