OCT Vibrography for Biomechanical Properties of Tissues

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues

Conditions
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Cornea, Skin Diseases, Gingival Diseases

Intervention / Treatment
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* Device: Optical imaging of the tissues


Participation Criteria
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Eligibility Criteria
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Group 1: 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 Group 2: 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 Group 3: 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 Group 4: Inclusion criteria: • Mild or moderate keratoconus subjects (age 18 - 40, N = 10) Exclusion criteria: • Subjects with K-max above 55 diopters (Pentacam imaging) are excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy cornea<br>Optical imaging of the cornea in healthy subjects | Device: Optical imaging of the tissues<br>* OCT vibrography<br>|
| Experimental: Healthy skin<br>Optical imaging of the skin in healthy subjects | Device: Optical imaging of the tissues<br>* OCT vibrography<br>|
| Experimental: Healthy gingiva<br>Optical imaging of the gingiva in healthy subjects | Device: Optical imaging of the tissues<br>* OCT vibrography<br>|
| Experimental: Keratoconus cornea<br>Optical imaging of the cornea in mild and moderate keratoconus | Device: Optical imaging of the tissues<br>* OCT vibrography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device. | Frequency and severity of all treatment-related adverse events | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin, biomechanics, cornea, gingiva, optical coherence tomography, vibrography