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Trial record 1 of 1 for:    NCT02582164
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Long-Working Distance OCT for Children (LWDOCT)

This study is currently recruiting participants.
Verified August 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02582164
First Posted: October 21, 2015
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Johns Hopkins University
The Hartwell Foundation
Information provided by (Responsible Party):
Duke University
  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: None (Open Label)
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 2018
Estimated Primary Completion Date: July 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Rothman AL, Tran-Viet D, Gustafson KE, Goldstein RF, Maguire MG, Tai V, Sarin N, Tong AY, Huang J, Kupper L, Cotten CM, Freedman SF, Toth CA. Poorer neurodevelopmental outcomes associated with cystoid macular edema identified in preterm infants in the intensive care nursery. Ophthalmology. 2015 Mar;122(3):610-9. doi: 10.1016/j.ophtha.2014.09.022. Epub 2014 Nov 4.
Tong AY, El-Dairi M, Maldonado RS, Rothman AL, Yuan EL, Stinnett SS, Kupper L, Cotten CM, Gustafson KE, Goldstein RF, Freedman SF, Toth CA. Evaluation of optic nerve development in preterm and term infants using handheld spectral-domain optical coherence tomography. Ophthalmology. 2014 Sep;121(9):1818-26. doi: 10.1016/j.ophtha.2014.03.020. Epub 2014 May 6.
Rothman AL, Folgar FA, Tong AY, Toth CA. Spectral domain optical coherence tomography characterization of pediatric epiretinal membranes. Retina. 2014 Jul;34(7):1323-34. doi: 10.1097/IAE.0000000000000113.
Maldonado RS, Yuan E, Tran-Viet D, Rothman AL, Tong AY, Wallace DK, Freedman SF, Toth CA. Three-dimensional assessment of vascular and perivascular characteristics in subjects with retinopathy of prematurity. Ophthalmology. 2014 Jun;121(6):1289-96. doi: 10.1016/j.ophtha.2013.12.004. Epub 2014 Jan 21.
Gramatikov BI, Irsch K, Guyton D. Optimal timing of retinal scanning during dark adaptation, in the presence of fixation on a target: the role of pupil size dynamics. J Biomed Opt. 2014;19(10):106014. doi: 10.1117/1.JBO.19.10.106014.
Irsch K, Gramatikov BI, Wu YK, Guyton DL. Improved eye-fixation detection using polarization-modulated retinal birefringence scanning, immune to corneal birefringence. Opt Express. 2014 Apr 7;22(7):7972-88. doi: 10.1364/OE.22.007972.
Gramatikov BI. Modern technologies for retinal scanning and imaging: an introduction for the biomedical engineer. Biomed Eng Online. 2014 Apr 29;13:52. doi: 10.1186/1475-925X-13-52. Review.
Carrasco-Zevallos OM, Qian R, Gahm N, Migacz J, Toth CA, Izatt JA. Long working distance OCT with a compact 2f retinal scanning configuration for pediatric imaging. Opt Lett. 2016 Nov 1;41(21):4891-4894. doi: 10.1364/OL.41.004891.

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02582164     History of Changes
Other Study ID Numbers: Pro00060018
First Submitted: September 3, 2015
First Posted: October 21, 2015
Last Update Posted: August 23, 2017
Last Verified: August 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


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