Multimodal Imaging in Central Serous Chorioretinopathy (IMO)
Primary Purpose
Central Serous Chorioretinopathy
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RTX1 IMAGIN EYE retinal camera
Sponsored by
About this trial
This is an interventional other trial for Central Serous Chorioretinopathy focused on measuring Optical Coherence Tomography, Retinal camera
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Previous photosensitivity
- Recent treatment with PhotoDynamic Therapy (PDT)
- Use of drugs inducing photosensitivity
Sites / Locations
- CHU Besançon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adaptative optics retinal camera
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02889185
First Posted
August 31, 2016
Last Updated
September 13, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02889185
Brief Title
Multimodal Imaging in Central Serous Chorioretinopathy
Acronym
IMO
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 4, 2018 (Actual)
Study Completion Date
December 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
Keywords
Optical Coherence Tomography, Retinal camera
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adaptative optics retinal camera
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
RTX1 IMAGIN EYE retinal camera
Intervention Description
In addition to the routine examination including OCT, an imaging using RTX1 IMAGIN EYE retinal camera will be performed.
Primary Outcome Measure Information:
Title
Workability of images of RTX1 IMAGIN EYE retinal camera
Description
Two readings of the images captured with adaptative optics retinal camera and assessment of their workability in routine care.
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Previous photosensitivity
Recent treatment with PhotoDynamic Therapy (PDT)
Use of drugs inducing photosensitivity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maher Saleh, MD PhD
Organizational Affiliation
CHU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multimodal Imaging in Central Serous Chorioretinopathy
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