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

Not Applicable

Not yet recruiting

• Conditions: Visual Acuity

• Registration Number: NCT06431295
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Study Start: 2025-10-01
• Primary Completion: 2027-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of times the experimental device when measuring visual acuity agreed with standard visual acuity measurements	Baseline	Number of subjects to have agreement between the visual acuity digital device and the clinical assessment

Secondary Outcome Measures

Name	Time	Method
Voice samples	Baseline	Total number of voice samples collected of spoken letters

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States