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Long-Working Distance OCT for Children (LWDOCT)

Primary Purpose

Retinal Diseases, Optic Nerve Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duke Biomedical Engineering's Long-working distance OCT
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Retinal Diseases focused on measuring Optical Coherence Tomography (OCT), Swept Source OCT

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duke Eye Center, Duke University Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Adult

Teenage minors

Children-pre teen

Target age group ≥6 months to ≤6 years

Arm Description

Duke Biomedical Engineering's long-working distance OCT system imaging of adult participants ages ≥18 year of age

Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥13-≤17 years of age

Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥7-≤12 years of age

Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥6 months to ≤6 years of age

Outcomes

Primary Outcome Measures

Percent of eyes with successful research imaging.
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.
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.
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.
The time from start of attempted imaging to imaging of both the macula and optic nerve of each eye.

Full Information

First Posted
September 3, 2015
Last Updated
January 27, 2022
Sponsor
Duke University
Collaborators
Johns Hopkins University, The Hartwell Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02582164
Brief Title
Long-Working Distance OCT for Children
Acronym
LWDOCT
Official Title
Long-Working Distance OCT System With Fixation Alignment for Pediatric Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Johns Hopkins University, The Hartwell Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Diseases, Optic Nerve Diseases
Keywords
Optical Coherence Tomography (OCT), Swept Source OCT

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adult
Arm Type
Experimental
Arm Description
Duke Biomedical Engineering's long-working distance OCT system imaging of adult participants ages ≥18 year of age
Arm Title
Teenage minors
Arm Type
Experimental
Arm Description
Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥13-≤17 years of age
Arm Title
Children-pre teen
Arm Type
Experimental
Arm Description
Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥7-≤12 years of age
Arm Title
Target age group ≥6 months to ≤6 years
Arm Type
Experimental
Arm Description
Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥6 months to ≤6 years of age
Intervention Type
Device
Intervention Name(s)
Duke Biomedical Engineering's Long-working distance OCT
Other Intervention Name(s)
LWD OCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of eyes with successful research imaging.
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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.
Description
Evaluation of retinal substructure morphology. Five substructures of retina include: Inner retinal complex, inner nuclear layer, outer plexiform layer, photoreceptor layer, RPE layer.
Time Frame
1 year
Title
Participant feedback, as measured by questionnaire.
Description
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.
Time Frame
1 year
Title
The time it takes to gather the research images.
Description
The time from start of attempted imaging to imaging of both the macula and optic nerve of each eye.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia A Toth, MD
Organizational Affiliation
Duke University Health System, Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center, Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25439600
Citation
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.
Results Reference
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PubMed Identifier
24811961
Citation
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.
Results Reference
background
PubMed Identifier
24691567
Citation
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.
Results Reference
background
PubMed Identifier
24461542
Citation
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.
Results Reference
background
PubMed Identifier
25349032
Citation
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.
Results Reference
background
PubMed Identifier
24718173
Citation
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.
Results Reference
background
PubMed Identifier
24779618
Citation
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.
Results Reference
background
PubMed Identifier
27805643
Citation
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.
Results Reference
background
PubMed Identifier
29057163
Citation
Qian R, Carrasco-Zevallos OM, Mangalesh S, Sarin N, Vajzovic L, Farsiu S, Izatt JA, Toth CA. Characterization of Long Working Distance Optical Coherence Tomography for Imaging of Pediatric Retinal Pathology. Transl Vis Sci Technol. 2017 Oct 16;6(5):12. doi: 10.1167/tvst.6.5.12. eCollection 2017 Oct.
Results Reference
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Long-Working Distance OCT for Children

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