SuspendedNot Applicable

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

Stopped: Study was suspended 4/16/2020 due to global pandemic. Plans to restart or permanently end the study are still being evaluated.

United States3 participantsStarted 2020-03-06

Plain-language 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.

Who can participate

Age range22 Years – 74 Years

SexALL

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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).

What they're measuring

Inter-observer reliability

Timeframe: Single 1 day visit

Intra-observer reliability

Timeframe: Single 1 day visit

Trial details

NCT IDNCT04312763

SponsorSecond Sight Medical Products

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-08

View on ClinicalTrials.gov More Blindness, Acquired trials