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

NCT ID: NCT07218835

Last Updated: 2025-10-20

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

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ocular Pathologies

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Auto-aligning Ocular imaging instrument

Intervention Type 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.

Interventions

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Auto-aligning Ocular imaging instrument

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Participant is unable to be imaged for any reason
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Kuo, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Eye Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Teresa Hawks

Role: CONTACT

919-681-1569

Other Identifiers

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HT9425-24-1-0870

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00117676

Identifier Type: -

Identifier Source: org_study_id

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