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

Second Sight Medical Products3 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blindness, Acquired

Eligibility

Sex: ALLMin age: 22 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * Subject is unsuitable for study participation as determined by Investigator's clinical judgment (with Sponsor's final input).

Locations (1)

Second Sight Medical Products, Inc.

Outcomes

Primary Outcomes

Inter-observer reliability

Intraclass correlation coefficient (ICC) of the overall FLORA-20 scores provided by each of the assessors (in-person and remote)