Long-Working Distance OCT for Children
- Conditions
- Optic Nerve DiseasesRetinal Diseases
- Interventions
- Device: Duke Biomedical Engineering's Long-working distance OCT
- Registration Number
- NCT02582164
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- Minor or adult undergoing eye examination at Duke Eye Center
- Adults with normal eye health enrolled as controls
- Have any ocular disease that restricts the ability to perform OCT scanning
- Minor under the age of 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Teenage minors Duke Biomedical Engineering's Long-working distance OCT Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥13-≤17 years of age Children-pre teen Duke Biomedical Engineering's Long-working distance OCT Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥7-≤12 years of age Target age group ≥6 months to ≤6 years Duke Biomedical Engineering's Long-working distance OCT Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥6 months to ≤6 years of age Adult Duke Biomedical Engineering's Long-working distance OCT Duke Biomedical Engineering's long-working distance OCT system imaging of adult participants ages ≥18 year of age
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Duke Eye Center, Duke University Health System
🇺🇸Durham, North Carolina, United States