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Robotic OCT for ER Anterior Eye Exams

Robotically Assisted Anterior Eye Examinations for Acute Eye Care

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06566339
Enrollment
93
Registered
2024-08-22
Start date
2026-06-29
Completion date
2026-12-30
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Develop and Test Robotically Assisted Imaging System for the Front of the Eye

Brief summary

The purpose of this study is to develop and test a robotically assisted imaging system for the front of the eye with a goal of helping eye care through the emergency department.

Interventions

DEVICERobotically Aligned Eye Imaging System

Robotically Aligned Eye Imaging System is a non-contact, micrometer scale imaging technique that provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop hardware systems and software algorithms necessary for acquiring ocular anterior segment images for those seeking eye care in emergency department settings.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adult patients 18 years of age and older * Presenting with ocular complaints potentially indicative of an anterior segment pathology (e.g., foreign body sensation, red eye, pain)

Exclusion criteria

* Hemodynamically unstable patients (e.g., undergoing active resuscitation efforts) * Patients with potential penetrating trauma to the eye who may need immediate surgical care

Design outcomes

Primary

MeasureTime frameDescription
SensitivityDay 1Sensitivity of the ED providers' 1. standard of care exam and 2. assessment of robotically acquired ocular imaging to detect referable ocular pathology in the study participants will be compared. The on-duty ophthalmologist exam will serve as the gold standard.
SpecificityDay 1Specificity of the ED providers' 1. standard of care exam and 2. assessment of robotically acquired ocular imaging to detect referable ocular pathology in the study participants will be compared. The on-duty ophthalmologist exam will serve as the gold standard.

Countries

United States

Contacts

CONTACTTerry H. Coordinator
teresa.hawks@duke.edu919-681-1569
PRINCIPAL_INVESTIGATORAnthony Kuo, MD

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026