Status:
SUSPENDED
A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals
Lead Sponsor:
Second Sight Medical Products
Collaborating Sponsors:
Boston Biomedical Associates
Conditions:
Blindness, Acquired
Eligibility:
All Genders
22-74 years
Brief Summary
This study aims to validate an observer-rated assessment titled "Functional Low-Vision Observer Rated Assessment (FLORA-20)", which comprises 20 functional vision tasks commonly performed in or around...
Eligibility Criteria
Inclusion
- Subjects implanted with the Argus II or Orion device
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subject is able to follow instructions and comply with FLORA-20 scheduling and completion of tasks
- Subject is willing to be filmed while performing the FLORA-20 tasks during the study
Exclusion
- Subject is unsuitable for study participation as determined by Investigator's clinical judgment (with Sponsor's final input).
Key Trial Info
Start Date :
March 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 20 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04312763
Start Date
March 6 2020
End Date
February 20 2025
Last Update
November 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Second Sight Medical Products, Inc.
Sylmar, California, United States, 91342