Retinal DetachmentDOREFANCT01767038
DOREFA (Retinal Detachment: Function and Anatomy)
A study testing OCT Spectralis and microperimetry in people with Retinal Detachment, run by Centre Hospitalier Universitaire Dijon at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- OCT Spectralis and microperimetry
- Type of treatment
- Surgery or procedure
- How many people
- 202 participants
- Where
- 10 sitesFrance
- Study dates
- Nov 2011to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Besançon
Besançon, 25030
CHU Bordeaux
Bordeaux, 33000
CHU Dijon
Dijon, 21000
CHU Grenoble
Grenoble, 38043
CHU Nancy
Nancy, 54035
CHU Nantes
Nantes, 44093
Hôpital Lariboisière
Paris, 75010
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
CHU Reims - Hôpital Robert Debré
Reims, 51092
CHU Strasbourg - Hôpital Civil
Strasbourg, 67091
About this study
Official title: Study of Anatomical and Functional Recovery Following Retinal Detachment: Identify Correlations Between Visual Acuity and SD-OCT and Microperimetry Findings.
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.
- Conditions
- Retinal Detachment
- Being tested
- OCT Spectralis, microperimetry
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT SpectralisProcedure or surgery
microperimetryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At six months after the intervention
Secondary outcomes (1)
Peripheral deficits and quantification of hypoautofluorescent zones.
Measured: At 3, 6 and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startNov 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767038
- Sponsor's protocol ID
- Creuzot-Garcher PHRC N 2010
- Acronym
- DOREFA
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2013
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33576133
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Anatomical and Functional Recovery Following Retinal Detachment: Identify Correlations Between Visual Acuity and SD-OCT and Microperimetry Findings.
- ClinicalTrials.gov ID
- NCT01767038
- Acronym / sponsor ID
- DOREFA / Creuzot-Garcher PHRC N 2010
- Conditions
- Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT Spectralis | Procedure or surgery | – |
| microperimetry | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
Peripheral deficits and quantification of hypoautofluorescent zones.
Time frame: At 3, 6 and 12 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 33576133Baudin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT Spectralis and microperimetry in people with Retinal Detachment, run by Centre Hospitalier Universitaire Dijon at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between functional recovery and the aspect of external layers using Spectral Domain OCT. (time frame: At six months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.