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

ClinicalTrials.gov ID: NCT04312763

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT04312763
Recruitment status: Suspended
Study type: Observational
Phase: Not listed
Lead sponsor: Second Sight Medical Products; Industry
Enrollment: 3 participants

Conditions and interventions

Conditions

Blindness, Acquired

Interventions

Not listed

Eligibility (public fields only)

Age range: 22 Years to 74 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 6, 2020 (Actual)
Primary completion: Dec 8, 2024 (Estimated)
Completion: Feb 20, 2025 (Estimated)
Last update posted: Nov 22, 2023

2020 – 2025

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Second Sight Medical Products, Inc.	Sylmar	California	91342	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04312763, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 22, 2023 · Synced Nov 15, 2026