Long-Working Distance OCT for Children (LWDOCT)

Duke University

Status: Completed

Conditions: Optic Nerve Diseases; Retinal Diseases

Treatments: Device: Duke Biomedical Engineering's Long-working distance OCT

Study type: Interventional

Funder types: Other

Identifiers

NCT02582164

Pro00060018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts 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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 4 patient groups

Adult

Experimental group

Description:

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

Treatment:

Device: Duke Biomedical Engineering's Long-working distance OCT

Teenage minors

Experimental group

Description:

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

Treatment:

Device: Duke Biomedical Engineering's Long-working distance OCT

Children-pre teen

Experimental group

Description:

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

Treatment:

Device: Duke Biomedical Engineering's Long-working distance OCT

Target age group ≥6 months to ≤6 years

Experimental group

Description:

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

Treatment:

Device: Duke Biomedical Engineering's Long-working distance OCT