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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02889185
Other study ID # P/2015/249
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date December 4, 2018

Study information

Verified date September 2019
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date December 4, 2018
Est. primary completion date December 4, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
RTX1 IMAGIN EYE retinal camera
In addition to the routine examination including OCT, an imaging using RTX1 IMAGIN EYE retinal camera will be performed.

Locations

Country Name City State
France CHU Besançon Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. day 1
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