Trials / Suspended
SuspendedNCT04312763
A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals
- Status
- Suspended
- Phase
- —
- Study type
- Observational
- Enrollment
- 3 (actual)
- Sponsor
- Second Sight Medical Products · Industry
- Sex
- All
- Age
- 22 Years – 74 Years
- Healthy volunteers
- Not accepted
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 a blind individual's home environment. This study shall be carried out with individuals who have an implanted visual prosthesis device. There are no new implantations or changes to the original implant or external wearables being studied or tested. Additionally, data from the study shall not be used alter standard of care or the user's treatment options.
Conditions
Timeline
- Start date
- 2020-03-06
- Primary completion
- 2024-12-08
- Completion
- 2025-02-20
- First posted
- 2020-03-18
- Last updated
- 2023-11-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04312763. Inclusion in this directory is not an endorsement.