Robotic OCT for ER Anterior Eye Exams

Not Applicable

Recruiting

• Conditions: Develop and Test Robotically Assisted Imaging System for the Front of the Eye
• Interventions: Device: Robotically Aligned Eye Imaging System

• Registration Number: NCT06566339
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-22
• Status Verified: 2024-11
• Study Start: 2024-11-12
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Imaging patients	Robotically Aligned Eye Imaging System	Participants eyes will be imaged with a Robotically aligned eye imaging system to help eye care through the emergency department

Primary Outcome Measures

Name	Time	Method
Specificity	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	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.

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States