## Protocol Section
### Identification Module
**NCT ID:** NCT06431295

**Brief Title:** Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements

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

#### Organization Study ID Info
**ID:** 23-007148
#### Organization
**Class:** OTHER
**Full Name:** Mayo Clinic
### Status Module
#### Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mayo Clinic

#### Responsible Party

**Investigator Affiliation:** Mayo Clinic

**Investigator Full Name:** Antonio J. Forte

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Visual Acuity

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SCREENING

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: FaceScan

**Label:** Digital Visual Acuity Test

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Digital Visual Acuity Test

**Description:** 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.

**Name:** FaceScan

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Number of subjects to have agreement between the visual acuity digital device and the clinical assessment

**Measure:** Number of times the experimental device when measuring visual acuity agreed with standard visual acuity measurements

**Time Frame:** Baseline

#### Secondary Outcomes

**Description:** Total number of voice samples collected of spoken letters

**Measure:** Voice samples

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Jacksonville

**Country:** United States

**Facility:** Mayo Clinic in Florida

**State:** Florida

**Zip:** 32224

#### Overall Officials

**Official 1:**

**Affiliation:** Mayo Clinic

**Name:** Antonio Forte, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
