Long-Working Distance OCT for Children

NCT02582164 | Completed DMC

• 1 other identifier: Pro00060018
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Diseases; Optic Nerve Diseases

Keywords

Optical Coherence Tomography (OCT); Swept Source OCT

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (3)

• 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

• Participant feedback, as measured by questionnaire.

  1 year

• The time it takes to gather the research images.

  1 year

Study Arms (4)

Adult

EXPERIMENTAL

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

Teenage minors

EXPERIMENTAL

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

Children-pre teen

EXPERIMENTAL

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

Target age group ≥6 months to ≤6 years

EXPERIMENTAL

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

Interventions

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.

Also known as: LWD OCT

Adult; Children-pre teen; Target age group ≥6 months to ≤6 years; Teenage minors

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Minor or adult undergoing eye examination at Duke Eye Center
• Adults with normal eye health enrolled as controls

You may not qualify if:

• Have any ocular disease that restricts the ability to perform OCT scanning
• Minor under the age of 6 months

Sponsors & Collaborators

• Duke University: lead
• Johns Hopkins University: collaborator
• The Hartwell Foundation: collaborator

Study Sites (1)

Duke Eye Center, Duke University Health System

Durham, North Carolina, 27710, United States

Location

Related Publications (9)

• 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.

  PMID: 25439600 BACKGROUND

• 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.

  PMID: 24811961 BACKGROUND

• 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.

  PMID: 24691567 BACKGROUND

• 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.

  PMID: 24461542 BACKGROUND

• 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.

  PMID: 25349032 BACKGROUND

• 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.

  PMID: 24718173 BACKGROUND

• 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.

  PMID: 24779618 BACKGROUND

• 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.

  PMID: 27805643 BACKGROUND

• 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.

  PMID: 29057163 BACKGROUND

MeSH Terms

Conditions

Retinal Diseases; Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Cynthia A Toth, MD

  Duke University Health System, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: October 21, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

US (1)