Long-Working Distance OCT for Children

• Register: ClinicalTrials.gov
• Last refreshed on: 7 February 2022
• Main ID: NCT02582164
• Date of registration: 03/09/2015
• Prospective Registration: No
• Primary sponsor: Duke University
• Public title: Long-Working Distance OCT for Children LWDOCT
• Scientific title: Long-Working Distance OCT System With Fixation Alignment for Pediatric Imaging
• Date of first enrolment: June 2015
• Target sample size: 49
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02582164
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Cynthia A Toth, MD
• Affiliation: Duke University Health System, Department of Ophthalmology

Key inclusion & exclusion 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



Age minimum: 6 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Optic Nerve Diseases

Retinal Diseases

Intervention(s)

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

Primary Outcome(s)

Percent of eyes with successful research imaging. [Time Frame: 1 year]

Secondary Outcome(s)

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]

Participant feedback, as measured by questionnaire. [Time Frame: 1 year]

The time it takes to gather the research images. [Time Frame: 1 year]

Secondary ID(s)

Pro00060018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Johns Hopkins University

The Hartwell Foundation