- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128150
High Resolution Retina Imaging (IHR)
October 14, 2019 updated by: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
To increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Anticipated)
1000
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
-
-
-
Paris, France, 75013
- Not yet recruiting
- Hôpital Pitié-Salpêtrière
-
Contact:
- Antonio Gallo, PH
-
Paris, France, 75010
- Not yet recruiting
- Hôpital Lariboisière
-
Contact:
- Valérie Krivosic, PH
-
Paris, France, 75012
- Recruiting
- Centre hospitalier National d'Ophtalmologie des Quinze-Vingts
-
-
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
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with pathologies affecting photoreceptors and the retinal vessels
Description
Inclusion Criteria:
- Persons over 12 years of age, of both sexes, presenting with retinal pathologies.
- Beneficiaries of the health insurance
Exclusion Criteria:
- Any abnormality preventing good quality OA imaging on both eyes
- Major under guardianship or curatorship
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolution of retina diseases
Time Frame: From date of inclusion until the date of last documented progression , assessed up to 5 years
|
Increase the clinical experience of using the rtx1 camera in various conditions with retinal impact
|
From date of inclusion until the date of last documented progression , assessed up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
January 17, 2018
Primary Completion (Anticipated)
January 30, 2023
Study Completion (Anticipated)
January 30, 2024
Study Registration Dates
First Submitted
October 14, 2019
First Submitted That Met QC Criteria
October 14, 2019
First Posted (Actual)
October 16, 2019
Study Record Updates
Last Update Posted (Actual)
October 16, 2019
Last Update Submitted That Met QC Criteria
October 14, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Diseases
- Genetic Diseases, Inborn
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Eye Diseases, Hereditary
- Retinal Dystrophies
- Macular Degeneration
- Diabetic Retinopathy
- Macular Edema
- Retinal Vein Occlusion
- Retinitis
- Retinitis Pigmentosa
- Retinal Degeneration
Other Study ID Numbers
- 2017-A03223-50 (Other Identifier: N° IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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