Optimize Pediatric OCT Imaging

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimize Pediatric OCT (Optical Coherence Tomography) Imaging: a Pilot Study

Conditions
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Retinal Disease, Glaucoma, Optic Nerve Diseases

Intervention / Treatment
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* Device: Investigational contact OCT system
* Device: Investigational noncontact OCT system:


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Healthy adult volunteers<br>Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=10) | Device: Investigational contact OCT system<br>* Theia imaging is developing handheld OCT systems bring state of the art OCT to the infant bedside. The Theia 1 widefield imaging system is a light weight, high speed (300 kHz), wide field of view (110°) OCT system that address the limitations of current commercial OCT systems. The system is cart mounted, enabling portable, bedside imaging. The system uses a 300 kHz swept source laser operating in 1060nm regime. The Theia system follows the same safety standards as all applicable laser safety standards (ANSI z80.36 or ISO 15004) as the currently approved prior OCT devices. This nearly 10-fold increase in acquisition speed dramatically reduces imaging time and enables acquisition of full retinal volumes in infants. The 110° field of view is provided via a re-usable contact lens that can be sterilized between imaging sessions.<br>* Other names: Theia 1 widefield imaging system;Device: Investigational noncontact OCT system:<br>* The investigational noncontact handheld OCT systems in this study is developed at Duke University as the result of collaboration between the Departments of Ophthalmology (Cynthia Toth, MD) and Biomedical Engineering (Joseph Izatt, PhD). This investigational device was previously reviewed and approved for use in adults, children, and neonates in nursery by: Intraoperative OCT Guidance of Intraocular Surgery study's (Pro00016827) Data Safety and Monitoring Board Plus (DSMB+) (PI: Toth and Izatt) The Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care study (Pro00069721) Data Safety and Monitoring Committee (DSMC) (PI: Toth) The systems were declared non-significant risk by the Duke University Health System (DUHS) Institutional Review Board under Pro00016827. Staff from the DUHS Clinical Engineering Department evaluated the systems and found that they meet the accepted hospital standards for electrical safety.<br>* Other names: Ultracompact swept source OCT system;|
| Pediatric participants<br>Pediatric patients with eye disease recruited from the patient population of Duke Eye Center (n=20) | Device: Investigational contact OCT system<br>* Theia imaging is developing handheld OCT systems bring state of the art OCT to the infant bedside. The Theia 1 widefield imaging system is a light weight, high speed (300 kHz), wide field of view (110°) OCT system that address the limitations of current commercial OCT systems. The system is cart mounted, enabling portable, bedside imaging. The system uses a 300 kHz swept source laser operating in 1060nm regime. The Theia system follows the same safety standards as all applicable laser safety standards (ANSI z80.36 or ISO 15004) as the currently approved prior OCT devices. This nearly 10-fold increase in acquisition speed dramatically reduces imaging time and enables acquisition of full retinal volumes in infants. The 110° field of view is provided via a re-usable contact lens that can be sterilized between imaging sessions.<br>* Other names: Theia 1 widefield imaging system;Device: Investigational noncontact OCT system:<br>* The investigational noncontact handheld OCT systems in this study is developed at Duke University as the result of collaboration between the Departments of Ophthalmology (Cynthia Toth, MD) and Biomedical Engineering (Joseph Izatt, PhD). This investigational device was previously reviewed and approved for use in adults, children, and neonates in nursery by: Intraoperative OCT Guidance of Intraocular Surgery study's (Pro00016827) Data Safety and Monitoring Board Plus (DSMB+) (PI: Toth and Izatt) The Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care study (Pro00069721) Data Safety and Monitoring Committee (DSMC) (PI: Toth) The systems were declared non-significant risk by the Duke University Health System (DUHS) Institutional Review Board under Pro00016827. Staff from the DUHS Clinical Engineering Department evaluated the systems and found that they meet the accepted hospital standards for electrical safety.<br>* Other names: Ultracompact swept source OCT system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Retinal thickness (microns) at the fovea and surrounding optic nerve. | Single imaging session (day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical Coherence Tomography (OCT)