OCT Vibrography for Biomechanical Properties of Tissues

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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Diseases; Gingival Diseases; Cornea
• Intervention / Treatment: Device: Optical imaging of the tissues

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seok-Hyun Yun, PhD; Phone Number: 6177688704; Email: syun@mgh.harvard.edu
• Study Contact Backup: Name: Jing Zhang, PhD; Phone Number: 6173730127; Email: jzhang110@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Sub-Investigator: Seok-Hyun Yun, PhD
      • Contact: Seok-Hyun Yun, PhD; Phone Number: 6177688704; Email: syun@mgh.harvard.edu
      • Contact: Jing Zhang, PhD; Phone Number: 617-373-0127; Email: jzhang110@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 = 20)

Exclusion criteria:

• Subjects with K-max above 60 diopters (Pentacam imaging) are excluded

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Seok-Hyun Yun, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.
• de Sanctis U, Loiacono C, Richiardi L, Turco D, Mutani B, Grignolo FM. Sensitivity and specificity of posterior corneal elevation measured by Pentacam in discriminating keratoconus/subclinical keratoconus. Ophthalmology. 2008 Sep;115(9):1534-9. doi: 10.1016/j.ophtha.2008.02.020. Epub 2008 Apr 11.
• Li X, Rabinowitz YS, Rasheed K, Yang H. Longitudinal study of the normal eyes in unilateral keratoconus patients. Ophthalmology. 2004 Mar;111(3):440-6. doi: 10.1016/j.ophtha.2003.06.020.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2023
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): August 28, 2026

Study Registration Dates

• First Submitted: February 26, 2023
• First Submitted That Met QC Criteria: February 26, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: skin; optical coherence tomography; cornea; biomechanics; gingiva; vibrography
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Eye Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Gingival Diseases; Corneal Diseases
• Other Study ID Numbers: 2023P000338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No