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OCT Vibrography for Biomechanical Properties of Tissues

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05759780
Enrollment
90
Registered
2023-03-08
Start date
2023-08-19
Completion date
2026-08-28
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cornea, Gingival Diseases, Skin Diseases

Keywords

biomechanics, cornea, skin, gingiva, optical coherence tomography, vibrography

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.

Interventions

DEVICEOptical imaging of the tissues

OCT vibrography

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER
Massachusetts Eye and Ear Infirmary
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.1 yearFrequency and severity of all treatment-related adverse events

Countries

United States

Contacts

CONTACTJing Zhang, PhD
jzhang110@mgh.harvard.edu6173730127
CONTACTSeok-Hyun Yun, PhD
syun@mgh.harvard.edu6177688704
PRINCIPAL_INVESTIGATORSeok-Hyun Yun, PhD

Massachusetts General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026