NCT01810107

Study to Evaluate the Efficacy of Optical Imaging to Evaluate the Anatomy of the Developing Pediatric Vocal Fold

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 557 (actual)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 1 Month – 99 Years
• Healthy volunteers: Accepted

Summary

The specific aim of this study is to develop a growth and development chart (similar to a height or weight chart for children) that identifies the pattern of development of the pediatric vocal cord lamina propria from a single to a three layer structure. A secondary aim is to identify whether this growth chart shows a pattern of linear development or whether there are clear critical periods of development.

Detailed description

The goal of this study is to identify critical periods of development when the lamina propria structure of the pediatric vocal fold matures. A Universal Modular Glottiscope will be utilized for adequate laryngeal exposure. An operating microscope will be used for magnification. This setup will allow for the Optical Coherence Tomography (OCT) imaging probe to be introduced using a laryngoscope to provide stability. The optical imaging probe will then be directed, or gently applied towards, the glottal surface, and an image field of 500 microns x 500 microns x 350 microns will be obtained. As the probe is moved along the medial and superior mucosal surfaces of the vocal folds, "real-time" images will be obtained and digitally stored for review. The digitally stored images will be assessed and analyzed for their optical characteristics. The optical imaging probe will then be withdrawn from the patient and the original operative procedure will then be performed. Images can be attained in both "non-contact" mode (where the probe tip remains in the space between each vocal fold) and "contact" mode (where the probe tip is gently placed against the glottal tissue to compress it). The contact mode allows for deeper imaging (much like an ultrasound), which would be useful in situations involving larger (thicker) vocal folds. The study will end when images are acquired from a range of developmental ages to be able to refine the optical characteristics of the optical imaging system. Adults have also been included in this study for comparison as OCT imaging in adults may confirm the number of vocal fold layers compared to children.

Conditions

• Vocal Fold Development

Interventions

Type	Name	Description
PROCEDURE	Children Examined with the OCT Probe	The child undergoing therapy will have the Optical Coherence Tomography (OCT) probe to examine the vocal fold.

Timeline

• Start date: 2011-07-01
• Primary completion: 2019-09-26
• Completion: 2019-12-21
• First posted: 2013-03-13
• Last updated: 2020-05-27

Locations

1 site across 1 country: United States