NCT06431295

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Oct 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
3.3 years until next milestone

Study Start

First participant enrolled

October 1, 2027

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

May 22, 2024

Last Update Submit

November 17, 2025

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Voice samples

    Baseline

Study Arms (1)

Digital Visual Acuity Test

EXPERIMENTAL

Subjects for an ophthalmological examination that includes a visual acuity examination at Mayo Clinic in Florida have a digital visual acuity test conducted with the FaceScan device.

Device: FaceScan

Interventions

FaceScanDEVICE

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.

Digital Visual Acuity Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥ 18 years) who come to Ophthalmology Clinic.
  • Willing and able to provide consent.

You may not qualify if:

  • Individuals \< 18 years of age.
  • Unable to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Study Officials

  • Antonio Forte, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2024

First Posted

May 28, 2024

Study Start (Estimated)

October 1, 2027

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)