Multimodal Imaging in Central Serous Chorioretinopathy | NCT02889185

Studies
Multimodal Imaging in Central Serous Chorioretinopathy

NCT02889185

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Terminated

Last Update Posted

Sep 16, 2019Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Central Serous Chorioretinopathy

Interventions

RTX1 IMAGIN EYE retinal camera

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Dec 4, 2018Actual

Completion Date

Dec 4, 2018Actual

First Submitted Date

Aug 31, 2016

First Submission Date that Met QC Criteria

Aug 31, 2016

First Posted Date

Sep 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2019

Last Update Posted Date

Sep 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adaptative optics retinal camera	Experimental		Device: RTX1 IMAGIN EYE retinal camera

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RTX1 IMAGIN EYE retinal camera	Device	In addition to the routine examination including OCT, an imaging using RTX1 IMAGIN EYE retinal camera will be performed.	Adaptative optics retinal camera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maher Saleh, MD PhD	CHU Besançon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besançon		Besançon		25000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056833	Central Serous Chorioretinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided