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NCT06431295 Clinical Trial

Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements

Visual Acuity Clinical Trial

Official title:
Human Performance Evaluation of a Digital Visual Acuity Device: Visual Acuity-001

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06431295
Other study ID # 23-007148
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date October 2024

Study information
Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to validate and determine the accuracy of the experimental device when measuring visual acuity versus our standard visual acuity measurements and to gather voice recordings of letters to help build a special system that recognizes spoken letters.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (= 18 years) who come to Ophthalmology Clinic. - Willing and able to provide consent. Exclusion Criteria: - Individuals < 18 years of age. - Unable to provide consent.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• FaceScan
Digital visual acuity device built for iOS ("iPhone") that conducts an assessment of visual acuity using a combination of integrated light detection and ranging (LiDAR) and voice processing.

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of times the experimental device when measuring visual acuity agreed with standard visual acuity measurements Number of subjects to have agreement between the visual acuity digital device and the clinical assessment Baseline
Secondary Voice samples Total number of voice samples collected of spoken letters Baseline
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