A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.
Study Overview
Brief Summary
The overall goal of this study is to develop OCT Vibrography (aka OCT elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo.
Detailed Description
The overall goal of this study is to develop OCT Vibrography (aka OCT elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo. The investigators aim to establish baseline data in healthy subjects, compare elastic moduli in different tissue types, and measure differences in elastic moduli between keratoconus and normal eyes. If successful, this project will provide useful, previously inaccessible elastic parameters and advance the investigators' understanding of the relationship between the bulk mechanical properties and the microstructure of the human tissue in vivo. This information can ultimately be used to improve the diagnosis and treatment of keratoconus, inflammatory skin diseases, and inflammatory gingiva diseases. More broadly, the technologies developed in this project will have relevance to other potential applications beyond the tissues in this research study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion criteria:
- •Subjects with healthy eyes (age 18 - 75, N = 50)
Exclusion Criteria
- •Subjects with history of eye diseases, and previous eye surgeries.
- •Subjects with diabetes, glaucoma family history
- •Subjects allergic to anesthetic eyedrop, especially proparacaine
- •Subjects with severe allergy
- •Subjects who have difficulty biting
- •Subjects who have recurrent corneal erosion
- •Inclusion criteria:
- •Subjects with healthy skin (age 18 - 75, N = 10)
- •Exclusion criteria:
- •Subjects with open cuts/sores on the skin, skin infection, or any contagious skin condition
- •Inclusion criteria:
- •Subjects with healthy gingiva (age 18 - 75, N = 10)
- •Exclusion criteria:
- •Subjects with open cuts/sores on the gingiva, gingiva infection, or any contagious gingiva condition
- •Inclusion criteria:
- •Mild or moderate keratoconus subjects (age 18 - 40, N = 20)
- •Exclusion criteria:
- •Subjects with K-max above 60 diopters (Pentacam imaging) are excluded
Arms & Interventions
Healthy gingiva
Optical imaging of the gingiva in healthy subjects
Intervention: Optical imaging of the tissues (Device)
Keratoconus cornea
Optical imaging of the cornea in mild and moderate keratoconus
Intervention: Optical imaging of the tissues (Device)
Healthy cornea
Optical imaging of the cornea in healthy subjects
Intervention: Optical imaging of the tissues (Device)
Healthy skin
Optical imaging of the skin in healthy subjects
Intervention: Optical imaging of the tissues (Device)
Outcomes
Primary Outcomes
Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.
Time Frame: 1 year
Frequency and severity of all treatment-related adverse events
Secondary Outcomes
No secondary outcomes reported
Investigators
Seok Hyun Yun
Professor of Dermatology
Massachusetts General Hospital