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High Resolution Retina Imaging (IHR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04128150
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Study Description
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Brief Summary:
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

Condition or disease
Retinitis Pigmentosa Maculopathy, Age Related Macular Dystrophy Macular Edema Retinal Degeneration Diabetic Retinopathy Occlusion Retinal Vein Hypertension

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: High Resolution Retina Imaging
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : January 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pathologies affecting photoreceptors and the retinal vessels
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128150


Contacts
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Contact: Tania RILCY +33 140021126 trilcy@15-20.fr
Contact: Hayet SERHANE +33 140021144 hserhane@15-20.fr

Locations
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France
Hôpital Lariboisière Not yet recruiting
Paris, France, 75010
Contact: Valérie Krivosic, PH         
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts Recruiting
Paris, France, 75012
Contact: Michel PAQUES, PU-PH    01 40 02 14 15    mpaques@15-20.fr   
Hôpital Pitié-Salpétrière Not yet recruiting
Paris, France, 75013
Contact: Antonio Gallo, PH         
Sponsors and Collaborators
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Investigators
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Principal Investigator: Michel PAQUES Centre Hospitalier National d'Ophtalmologie des Quinze-Vints
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
ClinicalTrials.gov Identifier: NCT04128150    
Other Study ID Numbers: 2017-A03223-50
2017-A03223-50 ( Other Identifier: N° IDRCB )
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Diabetic Retinopathy
Retinitis
Retinitis Pigmentosa
Macular Degeneration
Retinal Degeneration
Retinal Vein Occlusion
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases
 Diabetic Angiopathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn
Venous Thrombosis
Thrombosis
Embolism and Thrombosis