Multimodal Imaging in Central Serous Chorioretinopathy (IMO)

September 13, 2019 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Workability of images of RTX1 IMAGIN EYE retinal camera
Time Frame: day 1
Two readings of the images captured with adaptative optics retinal camera and assessment of their workability in routine care.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Maher Saleh, MD PhD, CHU Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 4, 2018

Study Completion (Actual)

December 4, 2018

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 5, 2016

Study Record Updates

Last Update Posted (Actual)

September 16, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2015/249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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