Try our beta test site
Trial record 1 of 1 for:    NCT02582164
Previous Study | Return to List | Next Study

Long-Working Distance OCT for Children (LWDOCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Duke University
Sponsor:
Collaborators:
Johns Hopkins University
The Hartwell Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02582164
First received: September 3, 2015
Last updated: March 20, 2017
Last verified: August 2016
  Purpose
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.

Condition Intervention
Retinal Diseases
Optic Nerve Diseases
Device: Duke Biomedical Engineering's Long-working distance OCT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Device Feasibility
Official Title: Long-Working Distance OCT System With Fixation Alignment for Pediatric Imaging

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.


Estimated Enrollment: 250
Study Start Date: June 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adult
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
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 Name: LWD OCT
Experimental: Teenage minors
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
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 Name: LWD OCT
Experimental: Children-pre teen
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
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 Name: LWD OCT
Experimental: Target age group ≥6 months to ≤6 years
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
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 Name: LWD OCT

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.

  Eligibility

Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02582164

Contacts
Contact: Michelle N McCall, MCAPM, BA 919-684-0544 michelle.mccall@duke.edu
Contact: Neeru Sarin, MBBS 919-668-5631 neeru.sarin@duke.edu

Locations
United States, North Carolina
Duke Eye Center, Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Michelle N McCall, MCAPM, BA    919-684-0544    michelle.mccall@duke.edu   
Contact: Neeru Sarin, MBBS    919-668-5341    neeru.sarin@duke.edu   
Principal Investigator: Cyntha A Toth, MD         
Sub-Investigator: Lejla Vajzovic, MD         
Sponsors and Collaborators
Duke University
Johns Hopkins University
The Hartwell Foundation
Investigators
Principal Investigator: Cynthia A Toth, MD Duke University Health System, Department of Ophthalmology
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02582164     History of Changes
Other Study ID Numbers: Pro00060018
Study First Received: September 3, 2015
Last Updated: March 20, 2017

Keywords provided by Duke University:
Optical Coherence Tomography (OCT)
Swept Source OCT

Additional relevant MeSH terms:
Retinal Diseases
Nervous System Diseases
Optic Nerve Diseases
Eye Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on March 29, 2017