Optimize Pediatric OCT Imaging

Recruiting

• Conditions: Retinal Disease; Glaucoma; Optic Nerve Diseases
• Interventions: Device: Investigational contact OCT system

• Registration Number: NCT06139523
• Lead Sponsor: Duke University

Brief Summary

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina.

The investigators hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality).

Detailed Description

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina.

The investigators plan to enroll 10 healthy adult volunteers and 20 pediatric patients in clinic or undergoing examination under anesthesia. This is an observational study. There are no known risks associated with handheld OCT imaging and no adverse events identified imaging with our prior investigational imaging with the same system. There is a risk of corneal abrasion with the contact imaging system (Theia imaging), however, this system is used in the setting of other contact imaging systems (such as RetCam fundus photography).

Imaging data will be downloaded to a secure server for protocol image processing, segmentation, and analysis per protocol in the Duke Advanced Research in SD/SSOCT Imaging (DARSI) Laboratory.

Study Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Study Start: 2024-01-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Group 1 - Healthy adult volunteers
• Subject is able and willing to consent to study participation
• Subject is more than 18 years of age
• Healthy adult volunteers without known ocular issues other than refractive error
• Pregnancy Reasonably Excluded Guide (PREG) evaluation on women of childbearing potential
• Group 2 - Pediatric participants
• Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian
• Parent/legal guardian is able and willing to consent to study participation
• Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center

Exclusion Criteria

• Group 1 - Healthy adult volunteers
• Students or employees under direct supervision of the investigators
• Subjects with prior problems with pupil dilation
• Pregnant woman if receiving dilating drops
• Group 2 - Pediatric participants
• Parent/legal guardian unwilling or unable to provide consent
• Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric participants	Investigational contact OCT system	Pediatric patients with eye disease recruited from the patient population of Duke Eye Center (n=20)
Group 1: Healthy adult volunteers	Investigational contact OCT system	Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=10)

Primary Outcome Measures

Name	Time	Method
Presence of abnormal retinal microanatomy as measured by OCT reading	Single imaging session (day 1)
Severity of abnormal retinal microanatomy as measured by OCT reading	Single imaging session (day 1)
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT analysis	Single imaging session (day 1)	Retinal thickness (microns) at the fovea and surrounding optic nerve.

Trial Locations

Locations (1)

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