Compact Auto-Aligning Multi-Modal Eye Imaging to Diagnose Traumatic Eye Injury

NCT07218835 | Not Yet Recruiting FDA Device

• 2 other identifiers: Pro00117676HT9425-24-1-0870
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test an investigational eye imaging device by taking pictures of participants eyes with a single image capture that takes only seconds.

Conditions

Ocular Pathologies

Outcome Measures

Primary Outcomes (4)

• Number of participants who found the eye imaging device easy to use

  up to 2 years

• Number of participants who found the eye imaging device mobile

  up to 2 years

• Number of participants who found the eye imaging device reliable

  up to 2 years

• Image quality as measured by the number of eye condition diagnoses that match official diagnoses

  Diagnoses made from the eye imaging device will be compared to the official diagnoses the patients received from a full eye exam in the clinic or emergency department.

  up to 2 years

Study Arms (1)

Tri-Modality, auto-aligning ocular imaging with compact handheld instrument

Color photography, anterior and posterior segment OCT images with the investigational eye imaging system will be taken of consented participant's eyes presenting within Duke Eye Center and Duke University emergency room

Device: Auto-aligning Ocular imaging instrument

Interventions

Auto-aligning Ocular imaging instrument DEVICE

Develop a tri-modality, auto-aligning ocular imaging instrument incorporating gross color photography, anterior and posterior segment OCT in a compact, handheld form factor.

Tri-Modality, auto-aligning ocular imaging with compact handheld instrument

Eligibility Criteria

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

Study Population

Duke Eye Center patients will be drawn from the Eye Center clinics and from Duke Emergency Department consulted by ophthalmologist in the Emergency Department.

You may qualify if:

• Ocular complaints potentially indicating anterior segment pathology (e.g., corneal abrasions, corneal edema, corneal scars)
• Ocular complaints potentially indicating posterior segment pathology (e.g., macular edema, neovascular, macular degeneration)

You may not qualify if:

• Participant is unable to be imaged for any reason

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Anthony Kuo, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Hawks

CONTACT

919-681-1569; teresa.hawks@duke.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2025
• First Posted: October 20, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 24, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)