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

Second Sight Medical Products

Status: Suspended

Conditions: Blindness, Acquired

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04312763

CP-11

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 22 to 74 years old

Volunteers: No Healthy Volunteers

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).