Optic Nerve Diseases, Retinal Diseases
Conditions
Keywords
Optical Coherence Tomography (OCT), Swept Source OCT
Brief summary
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
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.
Interventions
DEVICEDuke Biomedical Engineering's Long-working distance OCT
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.
Sponsors
Johns Hopkins University
The Hartwell Foundation
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of eyes with successful research imaging. | 1 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 year | Evaluation of retinal substructure morphology. Five substructures of retina include: Inner retinal complex, inner nuclear layer, outer plexiform layer, photoreceptor layer, RPE layer. |
| Participant feedback, as measured by questionnaire. | 1 year | 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. |
| The time it takes to gather the research images. | 1 year | The time from start of attempted imaging to imaging of both the macula and optic nerve of each eye. |
Countries
United States
Outcome results
None listed