Rhegmatogenous Retinal DetachmentNCT01343134
Anatomical and Functional Macular Changes in Retinal Detachment
An observational study of Rhegmatogenous Retinal Detachment, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The purpose of this study is to evaluate the correlation between morphologic changes in the outer retina and visual function after successful repair of rhegmatogenous retinal detachment with macula off. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Dec 2010
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with successful repair of rhegmatogenous retinal detachment after macula off and minimum 6 month follow-up after surgery
Who may be able to join
- Rhegmatogenous retinal detachment
Who cannot join
- Epiretinal membrane
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the correlation between morphologic changes in the outer retina and visual function after successful repair of rhegmatogenous retinal detachment with macula off.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments)
- Keywords
- Retina, Rhegmatogenous retinal detachment, Macular detachment, Spectral domain OCT, Microperimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments)Device
Measure the thickness of the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg)and perform central microperimetry using new OPKO Instruments OCT.
| Study group | Role | What they receive |
|---|---|---|
| Retinal detachment cohort | Not described Receives: Device: Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Investigators
- Catherine Creuzot-Garcher, MD;PhD, Study director, Ophthalmology department CHU DijonMarie Pierre Delolme, MD, Principal investigator, Ophthalmology Department CHU Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343134
- Sponsor's protocol ID
- Marie Pierre 01
- Status last verified
- Jan 2011
- First submitted
- 26 Apr 2011
- Last updated
- 16 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical and Functional Macular Changes in Retinal Detachment
- ClinicalTrials.gov ID
- NCT01343134
- Acronym / sponsor ID
- Marie Pierre 01
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- Retina, Rhegmatogenous retinal detachment, Macular detachment, Spectral domain OCT, Microperimetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Apr 2011 (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.
The purpose of this study is to evaluate the correlation between morphologic changes in the outer retina and visual function after successful repair of rhegmatogenous retinal detachment with macula off.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal detachment cohort | – | Device: Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with successful repair of rhegmatogenous retinal detachment after macula off and minimum 6 month follow-up after surgery
Key inclusion criteria (1 listed)
- Rhegmatogenous retinal detachment
Key exclusion criteria (1 listed)
- Epiretinal membrane
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 |
|---|---|---|
| Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments)Measure the thickness of the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg)and perform central microperimetry using new OPKO Instruments OCT. | Device | Retinal detachment cohort |
Primary outcome
Not reported in the source record.
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 16 May 2011.
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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.
Catherine Creuzot-Garcher, MD;PhD study director
Ophthalmology department CHU Dijon
Marie Pierre Delolme, MD principal investigator
Ophthalmology Department CHU Dijon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhegmatogenous Retinal Detachment, run by Centre Hospitalier Universitaire Dijon at 1 site 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 1 inclusion and 1 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 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
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 16 May 2011.