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A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals

NCT04312763 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2023-11-22

No results posted yet for this study

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

  • Blindness, Acquired

Sponsors & Collaborators

  • Boston Biomedical Associates

    collaborator OTHER

  • Second Sight Medical Products

    lead INDUSTRY

Principal Investigators

  • Uday Patel, PhD · Second Sight Medical Products, Inc.

Eligibility

Min Age
22 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2024-12-08
Completion
2025-02-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04312763 on ClinicalTrials.gov