Central Serous ChorioretinopathyIMONCT02889185
Multimodal Imaging in Central Serous Chorioretinopathy
A study testing RTX1 IMAGIN EYE retinal camera in people with Central Serous Chorioretinopathy, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims to assess the contribution of the multimodal imaging, combining a routine examination using Optical Coherence Tomography (OCT) with an imaging procedure using adaptive optics retinal camera. This is a feasibility study with a limited number of patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- RTX1 IMAGIN EYE retinal camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to 4 Dec 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent form
- Beneficiary/affiliated to French social security/social healthcare
- Active ou chronic Central Serous Chorioretinopathy on at least one eye
- Absence of other known ophthalmological pathology or of any ophthalmological conditions revealed during the examination
Who cannot join
- Legal incapacity or limited legal capacity
- Predictable poor adherence
- Subject without health insurance
- Pregnant or breatfeeding women
- Sujet étant dans la période d'exclusion d'une autre étude ou prévue par le "fichier national des volontaires"
- Presence of transparent medium opacity damaging images quality
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- Previous photosensitivity
- Recent treatment with PhotoDynamic Therapy (PDT)
- Use of drugs inducing photosensitivity
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the contribution of the multimodal imaging, combining a routine examination using Optical Coherence Tomography (OCT) with an imaging procedure using adaptive optics retinal camera.
This is a feasibility study with a limited number of patients.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- RTX1 IMAGIN EYE retinal camera
- Keywords
- Optical Coherence Tomography, Retinal camera
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTX1 IMAGIN EYE retinal cameraDevice
In addition to the routine examination including OCT, an imaging using RTX1 IMAGIN EYE retinal camera will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Adaptative optics retinal camera | Experimental | Not described Receives: Device: RTX1 IMAGIN EYE retinal camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Workability of images of RTX1 IMAGIN EYE retinal camera
Two readings of the images captured with adaptative optics retinal camera and assessment of their workability in routine care.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startApr 2016
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maher Saleh, MD PhD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889185
- Sponsor's protocol ID
- P/2015/249
- Acronym
- IMO
- Status last verified
- Sep 2019
- First submitted
- 31 Aug 2016
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging in Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT02889185
- Acronym / sponsor ID
- IMO / P/2015/249
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- Optical Coherence Tomography, Retinal camera
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 5 Sep 2016 (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.
This study aims to assess the contribution of the multimodal imaging, combining a routine examination using Optical Coherence Tomography (OCT) with an imaging procedure using adaptive optics retinal camera.
This is a feasibility study with a limited number of patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptative optics retinal camera | Experimental | Device: RTX1 IMAGIN EYE retinal camera |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent form
- Beneficiary/affiliated to French social security/social healthcare
- Active ou chronic Central Serous Chorioretinopathy on at least one eye
- Absence of other known ophthalmological pathology or of any ophthalmological conditions revealed during the examination
Key exclusion criteria (9 listed)
- Legal incapacity or limited legal capacity
- Predictable poor adherence
- Subject without health insurance
- Pregnant or breatfeeding women
- Sujet étant dans la période d'exclusion d'une autre étude ou prévue par le "fichier national des volontaires"
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 |
|---|---|---|
| RTX1 IMAGIN EYE retinal cameraIn addition to the routine examination including OCT, an imaging using RTX1 IMAGIN EYE retinal camera will be performed. | Device | Adaptative optics retinal camera |
Primary outcome
Workability of images of RTX1 IMAGIN EYE retinal camera
Time frame: day 1
Two readings of the images captured with adaptative optics retinal camera and assessment of their workability in routine care.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Maher Saleh, MD PhD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RTX1 IMAGIN EYE retinal camera in people with Central Serous Chorioretinopathy, run by Centre Hospitalier Universitaire de Besancon 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 16 Sep 2019. 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 was stopped early. Results are not available in the source record.
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?
Workability of images of RTX1 IMAGIN EYE retinal camera (time frame: day 1). It is what the study was designed to measure, not a finding.
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 Sep 2019.