Long-Working Distance OCT for Children

Study Overview
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Brief Summary
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Young children age 6 month to 6 years are often not able to cooperate for advanced OCT eye imaging. The purpose of this study is to investigate the use of a novel long-working distance swept source (SS) optical coherence tomography imaging system with fixation alignment for use first in young adults, older children, and then young children ages 6 months to 6 years. The investigator's future goal is to obtain important retinal and optic nerve information from OCT in clinic in these young children.

Detailed Description
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The overall objective of this study is to examine the utility of a long-working distance high speed SSOCT system along with technology to identify and use movies, etc. to aid with fixation. This study would be the first testing of such a system, first in adults and then moving to older children who could provide feedback, and then to young children. This imaging data will be compared to other clinical tests and images collected during regular health care and eye examinations.

Official Title
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Long-Working Distance OCT System With Fixation Alignment for Pediatric Imaging

Conditions
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Retinal Diseases, Optic Nerve Diseases

Intervention / Treatment
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* Device: Duke Biomedical Engineering's Long-working distance OCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minor or adult undergoing eye examination at Duke Eye Center Adults with normal eye health enrolled as controls Exclusion Criteria: Have any ocular disease that restricts the ability to perform OCT scanning Minor under the age of 6 months

Ages Eligible for Study
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Minimum Age: 6 Months

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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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult<br>Duke Biomedical Engineering's long-working distance OCT system imaging of adult participants ages ≥18 year of age | Device: Duke Biomedical Engineering's Long-working distance OCT<br>* The long-distance SSOCT system designed by Duke University Biomedical Engineering Department allows the user to quickly image an eye at a much greater distance (typically 20-40 cm away but this could be longer or shorter). This could potentially be used while briefly attracting a child's attention to an illuminated image over the imaging lens. With this methodology, young patients would not need to place their eye close to the system and could be rapidly imaged during the short interval while they glance at the image from the correct distance.<br>* Other names: LWD OCT;|
| Experimental: Teenage minors<br>Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥13-≤17 years of age | Device: Duke Biomedical Engineering's Long-working distance OCT<br>* The long-distance SSOCT system designed by Duke University Biomedical Engineering Department allows the user to quickly image an eye at a much greater distance (typically 20-40 cm away but this could be longer or shorter). This could potentially be used while briefly attracting a child's attention to an illuminated image over the imaging lens. With this methodology, young patients would not need to place their eye close to the system and could be rapidly imaged during the short interval while they glance at the image from the correct distance.<br>* Other names: LWD OCT;|
| Experimental: Children-pre teen<br>Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥7-≤12 years of age | Device: Duke Biomedical Engineering's Long-working distance OCT<br>* The long-distance SSOCT system designed by Duke University Biomedical Engineering Department allows the user to quickly image an eye at a much greater distance (typically 20-40 cm away but this could be longer or shorter). This could potentially be used while briefly attracting a child's attention to an illuminated image over the imaging lens. With this methodology, young patients would not need to place their eye close to the system and could be rapidly imaged during the short interval while they glance at the image from the correct distance.<br>* Other names: LWD OCT;|
| Experimental: Target age group ≥6 months to ≤6 years<br>Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥6 months to ≤6 years of age | Device: Duke Biomedical Engineering's Long-working distance OCT<br>* The long-distance SSOCT system designed by Duke University Biomedical Engineering Department allows the user to quickly image an eye at a much greater distance (typically 20-40 cm away but this could be longer or shorter). This could potentially be used while briefly attracting a child's attention to an illuminated image over the imaging lens. With this methodology, young patients would not need to place their eye close to the system and could be rapidly imaged during the short interval while they glance at the image from the correct distance.<br>* Other names: LWD OCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of eyes with successful research imaging. | The primary outcome of this study is the percent of eyes with successful research imaging of retinal and optic nerve microanatomy including the following: the inner surface and retinal pigment epithelial (RPE) layers of the macula, a full cross section of optic nerve, identification of either foveal center or severe pathology that obscures foveal depression and the presence or absence of 5 substructures of retina (Inner retinal complex, inner nuclear layer, outer plexiform layer, photoreceptor layer, RPE layer). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of eyes with 5 substructures of retina capable of being determined as deformed, containing cystoid spaces or abnormal (> 50%) thickening or thinning of layers. | Evaluation of retinal substructure morphology. Five substructures of retina include: Inner retinal complex, inner nuclear layer, outer plexiform layer, photoreceptor layer, RPE layer. | 1 year | 
| Participant feedback, as measured by questionnaire. | Scoring of participant feedback from questionnaire on: longevity of imaging, ease of finding or fixating on a target and comfortability during imaging. Parents and children will complete questionnaire together. | 1 year | 
| The time it takes to gather the research images. | The time from start of attempted imaging to imaging of both the macula and optic nerve of each eye. | 1 year | 

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