Visual Field Analysis With Artificial Intelligence

NCT06920290 | Active Not Recruiting FDA Device

• 1 other identifier: WCG-20251396
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze visual field data from healthy participants. This data will be used to develop and optimize a new visual field perimeter test. The test will incorporate an advanced algorithm, which may include the use of Artificial Intelligence (AI), to enhance accuracy and efficiency in identifying test points.

Conditions

Glaucoma; Visual Field Defect

Keywords

Visual field test; Visual field defect; Perimetry; Virtual Reality; Glaucoma; Artificial Intelligence; Threshold Perimetry

Outcome Measures

Primary Outcomes (2)

• Brightness Threshold

  At each position of the peripheral visual field, a healthy individual's ability to see a test point will be measured. The brightness (measured in apostilbs) along a logarithmic scale (0.1 dB to 1000 dB) will be adjusted and the threshold will be defined as a brightness at which the healthy individual can see that test point \> 50% of the time.

  Within a 10 minute test

• Duration Threshold

  At each position of the peripheral visual field, a healthy individual's ability to see a test point will be measured. The duration (measured in seconds) will be adjusted and the threshold will be defined as the time at which the healthy individual can see that test point \> 50% of the time.

  Within a 10 minute test

Study Arms (1)

Healthy

* Healthy adults aged 18 years or older. * Best corrected visual acuity of 20/40 or better in each eye. * Normal optic nerve appearance upon clinical examination.

Device: Visual Field Perimeter Optimized with Eye Gaze Capture and Artificial Intelligence

Interventions

Visual Field Perimeter Optimized with Eye Gaze Capture and Artificial Intelligence DEVICE

1. Natural Eye Movement To the best of our knowledge, this is the first visual field perimeter software that allows users to move their eyes naturally during the test. Previous visual field tests required that patients maintain a central gaze throughout the test as test points flashed in the periphery of their vision; our test allows patients to look directly at these test points. 2. Simplified Data Capture To the best of our knowledge, this is the first visual field perimeter software that reliably eliminates the need for a hand-held clicker to register test points as the user sees them. 3. Attention Monitoring In previous tests, staring at a central spot could induce sleepiness and inattention; our test employs a software monitor that pauses the test, gives encouragement when appropriate, and allows the patient to regain focus. This allows for far greater accuracy in data reporting. 4. Artificial Intelligence (AI) Our test uses AI to optimize the test parameters.

Also known as: Advanced Visual Field Perimeter, Visual Field Analyzer Software

Healthy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy individuals with healthy eyes. The participants will be of all backgrounds so that the test results can be generalized to all individuals.

You may qualify if:

• Healthy adults aged 18 years or older.
• Best corrected visual acuity of 20/40 or better in each eye.
• Normal optic nerve appearance upon clinical examination.

You may not qualify if:

• Best corrected visual acuity worse than 20/40.
• Cup-to-disc ratio greater than 0.5.
• Previously documented glaucoma or optic neuropathy.
• Any significant ocular or neurological condition that may impact visual field.
• Inability to comply with study procedures.

Sponsors & Collaborators

• Sight Intelligence Engineering Corporation: lead

Study Sites (1)

Sight Intelligence Engineering

Alexandria, Virginia, 22306, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, MD, CEO

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 9, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)