Pigmentary RetinopathyNCT03510234
Self-confidence Study in Patients With Argus II Artificial Retina
An observational study of Pigmentary Retinopathy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
To evaluate whether the use of the Argus II retinal prosthesis improves the confidence and self-esteem of patients with advanced retinopathy pigmentosa Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pigmentary Retinopathy
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2018to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient already operated in France with artificial retina and having 1 year of follow-up
Who may be able to join
- 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
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service D'Ophtalmologie
Strasbourg, 67091
David GAUCHER, MD, PhD, 33 3 69 55 11 15, david.gaucher@chru-strasbourg.fr
Arnaud Messerlin, MD, 33 3 69 55 11 15, arnaud.messerlin@chru-strasbourg.fr
About this study
To evaluate whether the use of the Argus II retinal prosthesis improves the confidence and self-esteem of patients with advanced retinopathy pigmentosa
- Conditions
- Pigmentary Retinopathy
- Keywords
- Pigmentary retinopathy, Argus II retinal prosthesis, Self-confidence
- Medical subject headings
- Retinitis Pigmentosa
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-confidence
Evaluation of Self-confidence via a questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start23 Feb 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmentary RetinopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David GAUCHER, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510234
- Sponsor's protocol ID
- 6954
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-confidence Study in Patients With Argus II Artificial Retina
- ClinicalTrials.gov ID
- NCT03510234
- Acronym / sponsor ID
- 6954
- Conditions
- Pigmentary Retinopathy
- Keywords
- Pigmentary retinopathy, Argus II retinal prosthesis, Self-confidence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether the use of the Argus II retinal prosthesis improves the confidence and self-esteem of patients with advanced retinopathy pigmentosa
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient already operated in France with artificial retina and having 1 year of follow-up
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-confidence
Time frame: 12 months
Evaluation of Self-confidence via a questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David GAUCHER, MD, PhD study director
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pigmentary Retinopathy, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David GAUCHER, MD, PhD (33 3 69 55 11 15, david.gaucher@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-confidence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.