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

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04312763

Acronym

FLORA-20

Enrollment

Registered

2020-03-18

Start date

2020-03-06

Completion date

2025-02-20

Last updated

2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blindness, Acquired

Keywords

Observer-rated instrument

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

22 Years to 74 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
Inter-observer reliability	Single 1 day visit	Intraclass correlation coefficient (ICC) of the overall FLORA-20 scores provided by each of the assessors (in-person and remote)
Intra-observer reliability	Single 1 day visit	ICC of the overall FLORA-20 scores provided by the same assessor, assessed and re-assessed at two different time points

Secondary

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

Countries

United States

Outcome results