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Clinical Trials/NCT06566339
NCT06566339RecruitingNot Applicable

Robotically Assisted Anterior Eye Examinations for Acute Eye Care

Duke University2 sites in 1 country93 target enrollmentStarted: June 29, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
93
Locations
2
Primary Endpoint
Specificity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Experimental: Imaging patients

Experimental

Participants eyes will be imaged with a Robotically aligned eye imaging system to help eye care through the emergency department

Intervention: Robotically Aligned Eye Imaging System (Device)

Standard of care exam

No Intervention

ED providers' standard of care exam

Outcomes

Primary Outcomes

Specificity

Time Frame: Day 1

Specificity 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.

Sensitivity

Time Frame: Day 1

Sensitivity 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Duke University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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