Long-Working Distance OCT for Children

Retinal Diseases Clinical Trial

— LWDOCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582164
• Other study ID #: Pro00060018
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 1, 2018

Study information

• Verified date: January 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Optic Nerve Diseases
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Eye Center, Duke University Health System	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Johns Hopkins University, The Hartwell Foundation

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year