NCT02889185

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2018

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

August 31, 2016

Last Update Submit

September 13, 2019

Conditions

Central Serous Chorioretinopathy

Keywords

Optical Coherence TomographyRetinal camera

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Adaptative optics retinal camera

EXPERIMENTAL
Device: RTX1 IMAGIN EYE retinal camera

Interventions

RTX1 IMAGIN EYE retinal cameraDEVICE

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

Adaptative optics retinal camera

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Legal incapacity or limited legal capacity
  • Predictable poor adherence
  • Subject without health insurance
  • Pregnant or breatfeeding women
  • Presence of transparent medium opacity damaging images quality
  • Previous photosensitivity
  • Recent treatment with PhotoDynamic Therapy (PDT)
  • Use of drugs inducing photosensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Maher Saleh, MD PhD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 5, 2016

Study Start

April 1, 2016

Primary Completion

December 4, 2018

Study Completion

December 4, 2018

Last Updated

September 16, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)