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

NCT ID: NCT06431295

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2027-10-01

Study Completion Date

2029-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Visual Acuity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Digital Visual Acuity Test

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.

Group Type EXPERIMENTAL

FaceScan

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Antonio J. Forte

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Forte, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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23-007148

Identifier Type: -

Identifier Source: org_study_id

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