IMO: Multimodal Imaging in Central Serous Chorioretinopathy

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Terminated

CT.gov ID

NCT02889185

Collaborator

(none)

Enrollment

Location

Arm

32.1

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Central Serous Chorioretinopathy	Device: RTX1 IMAGIN EYE retinal camera	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Dec 4, 2018

Actual Study Completion Date :

Dec 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adaptative optics retinal camera	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.

Arm

Intervention/Treatment

Experimental: Adaptative optics retinal camera

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.

Outcome Measures

Primary Outcome Measures

Workability of images of RTX1 IMAGIN EYE retinal camera [day 1]
Two readings of the images captured with adaptative optics retinal camera and assessment of their workability in routine care.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Besançon	Besançon		France	25000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

Principal Investigator: Maher Saleh, MD PhD, CHU Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT02889185

Other Study ID Numbers:

P/2015/249

First Posted:

Sep 5, 2016

Last Update Posted:

Sep 16, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Centre Hospitalier Universitaire de Besancon

Optical Coherence Tomography

Retinal camera

Additional relevant MeSH terms:

Central Serous Chorioretinopathy

Study Results

No Results Posted as of Sep 16, 2019