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

Blindness, Acquired Clinical Trial

— FLORA-20  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04312763
• Other study ID #: CP-11
• Status: Suspended
• Start date: March 6, 2020
• Est. completion date: February 20, 2025

Study information

• Verified date: November 2023
• Source: Second Sight Medical Products
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 3
• Est. completion date: February 20, 2025
• Est. primary completion date: December 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 74 Years

Eligibility

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).

Related Conditions & MeSH terms

• Blindness
• Blindness, Acquired
• Vision, Low

Locations

Country	Name	City	State
United States	Second Sight Medical Products, Inc.	Sylmar	California

Sponsors (2)

Lead Sponsor	Collaborator
Second Sight Medical Products	Boston Biomedical Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Improvement in Average Performance, ON vs. OFF	Paired t-test to determine if there is a statistically significant improvement in average performance from ON vs. OFF	Single 1 day visit
Secondary	Clinical Meaningfulness (Effect Size)	Cohen's d calculation of overall FLORA-20 scores between device ON vs. OFF	Single 1 day visit
Secondary	Internal consistency - Cronbach's alpha	Cronbach's alpha of the individual FLORA-20 task scores	Single 1 day visit
Secondary	Internal consistency - item-total correlations	Item-total correlations for each FLORA-20 task	Single 1 day visit