Self-confidence Study in Patients With Argus II Artificial Retina
July 4, 2018 updated by: University Hospital, Strasbourg, France
To evaluate whether the use of the Argus II retinal prosthesis improves the confidence and self-esteem of patients with advanced retinopathy pigmentosa
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
18
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
-
-
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Strasbourg, France, 67091
- Recruiting
- Service d'Ophtalmologie
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Contact:
- David GAUCHER, MD, PhD
- Phone Number: 33 3 69 55 11 15
- Email: david.gaucher@chru-strasbourg.fr
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Contact:
- Arnaud Messerlin, MD
- Phone Number: 33 3 69 55 11 15
- Email: arnaud.messerlin@chru-strasbourg.fr
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Principal Investigator:
- David GAUCHER, MD, PhD
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Sub-Investigator:
- David Messerlin, MD
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-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient already operated in France with artificial retina and having 1 year of follow-up
Description
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
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 |
|---|---|---|
|
Self-confidence
Time Frame: 12 months
|
Evaluation of Self-confidence via a questionnaire
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: David GAUCHER, MD, PhD, University Hospital, Strasbourg, France
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)
February 23, 2018
Primary Completion (ANTICIPATED)
February 1, 2019
Study Completion (ANTICIPATED)
February 1, 2019
Study Registration Dates
First Submitted
February 26, 2018
First Submitted That Met QC Criteria
April 25, 2018
First Posted (ACTUAL)
April 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 6, 2018
Last Update Submitted That Met QC Criteria
July 4, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6954 (Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.