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Self-confidence Study in Patients With Argus II Artificial Retina

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03510234
Recruitment Status : Unknown
Verified February 2018 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : April 27, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:
To evaluate whether the use of the Argus II retinal prosthesis improves the confidence and self-esteem of patients with advanced retinopathy pigmentosa

Condition or disease
Pigmentary Retinopathy

Study Design
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Study Type : Observational
Estimated Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Self-confidence Study in Patients With Argus II Artificial Retina
Actual Study Start Date : February 23, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

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. Self-confidence [ Time Frame: 12 months ]
    Evaluation of Self-confidence via a questionnaire


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient already operated in France with artificial retina and having 1 year of follow-up
Criteria

Inclusion Criteria:

  • Major patient (≥18 years old)
  • Patient already operated in France with artificial retina and having 1 year of follow-up
  • Patient who has agreed to use his medical data for research purposes

Exclusion Criteria:

- Refusal to participate in the study

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): NCT03510234


Contacts
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Contact: David GAUCHER, MD, PhD 33 3 69 55 11 15 david.gaucher@chru-strasbourg.fr
Contact: Arnaud Messerlin, MD 33 3 69 55 11 15 arnaud.messerlin@chru-strasbourg.fr

Locations
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France
Service D'Ophtalmologie Recruiting
Strasbourg, France, 67091
Contact: David GAUCHER, MD, PhD    33 3 69 55 11 15    david.gaucher@chru-strasbourg.fr   
Contact: Arnaud Messerlin, MD    33 3 69 55 11 15    arnaud.messerlin@chru-strasbourg.fr   
Principal Investigator: David GAUCHER, MD, PhD         
Sub-Investigator: David Messerlin, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Study Director: David GAUCHER, MD, PhD University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03510234    
Other Study ID Numbers: 6954
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Pigmentary retinopathy
Argus II retinal prosthesis
Self-confidence
Additional relevant MeSH terms:
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Retinal Diseases
Retinitis Pigmentosa
Eye Diseases
Eye Diseases, Hereditary
 Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn