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Completed

NCT Number: NCT02582164

Long-Working Distance OCT for Children

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.

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Key information

Conditions

Retinal Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Eye Center, Duke University Health System

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duke Biomedical Engineering's Long-working distance OCT

Device

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.

Other names: LWD OCT

Primary outcomes

  1. Percent of eyes with successful research imaging.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

  2. Participant feedback, as measured by questionnaire.

    Time frame: 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.

  3. The time it takes to gather the research images.

    Time frame: 1 year

    The time from start of attempted imaging to imaging of both the macula and optic nerve of each eye.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Johns Hopkins University
  • The Hartwell Foundation

Registry information

Official study title

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

Acronym: LWDOCT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 21, 2015
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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