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

NCT04312763 | Suspended

• 1 other identifier: CP-11
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Observer-rated instrument

Outcome Measures

Primary Outcomes (2)

• Inter-observer reliability

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

  Single 1 day visit

• Intra-observer reliability

  ICC of the overall FLORA-20 scores provided by the same assessor, assessed and re-assessed at two different time points

  Single 1 day visit

Secondary Outcomes (4)

• Improvement in Average Performance, ON vs. OFF

  Single 1 day visit

• Clinical Meaningfulness (Effect Size)

  Single 1 day visit

• Internal consistency - Cronbach's alpha

  Single 1 day visit

• Internal consistency - item-total correlations

  Single 1 day visit

Eligibility Criteria

• Age: 22 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 30 users with the Argus II or Orion system from the US will be enrolled.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Second Sight Medical Products: lead
• Boston Biomedical Associates: collaborator

Study Sites (1)

Second Sight Medical Products, Inc.

Sylmar, California, 91342, United States

Location

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Uday Patel, PhD

  Second Sight Medical Products, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: March 6, 2020
• Primary Completion: December 8, 2024
• Study Completion: February 20, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)