Clinical Trial: Long-Working Distance OCT for Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Duke University

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

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    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. [ Time Frame: 1 year ]
    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. [ Time Frame: 1 year ]
    The time from start of attempted imaging to imaging of both the macula and optic nerve of each eye.


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: September 3, 2015
Date Started: June 2015
Date Completion: July 2017
Last Updated: March 20, 2017
Last Verified: August 2016