NCT03510234

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 6, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

February 26, 2018

Last Update Submit

July 4, 2018

Conditions

Pigmentary Retinopathy

Keywords

Pigmentary retinopathyArgus II retinal prosthesisSelf-confidence

Outcome Measures

Primary Outcomes (1)

  • Self-confidence

    Evaluation of Self-confidence via a questionnaire

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient already operated in France with artificial retina and having 1 year of follow-up

You may qualify if:

  • 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

You may not qualify if:

  • \- Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service D'Ophtalmologie

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • David GAUCHER, MD, PhD

    University Hospital, Strasbourg, France

    STUDY DIRECTOR

Central Study Contacts

David GAUCHER, MD, PhD

CONTACT

33 3 69 55 11 15david.gaucher@chru-strasbourg.fr

Arnaud Messerlin, MD

CONTACT

33 3 69 55 11 15arnaud.messerlin@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

April 27, 2018

Study Start

February 23, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

July 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)