OCT Vibrography for Biomechanical Properties of Tissues

NCT ID: NCT05759780

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-19

Study Completion Date

2026-08-28

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.

Conditions

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Cornea Skin Diseases Gingival Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy cornea

Optical imaging of the cornea in healthy subjects

Group Type EXPERIMENTAL

Optical imaging of the tissues

Intervention Type DEVICE

OCT vibrography

Healthy skin

Optical imaging of the skin in healthy subjects

Group Type EXPERIMENTAL

Optical imaging of the tissues

Intervention Type DEVICE

OCT vibrography

Healthy gingiva

Optical imaging of the gingiva in healthy subjects

Group Type EXPERIMENTAL

Optical imaging of the tissues

Intervention Type DEVICE

OCT vibrography

Keratoconus cornea

Optical imaging of the cornea in mild and moderate keratoconus

Group Type EXPERIMENTAL

Optical imaging of the tissues

Intervention Type DEVICE

OCT vibrography

Interventions

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Optical imaging of the tissues

OCT vibrography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

• Subjects with healthy eyes (age 18 - 75, N = 50)


• Subjects with healthy skin (age 18 - 75, N = 10)


• Subjects with healthy gingiva (age 18 - 75, N = 10)


• Mild or moderate keratoconus subjects (age 18 - 40, N = 20)

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:


• Subjects with open cuts/sores on the skin, skin infection, or any contagious skin condition

Group 3:


• Subjects with open cuts/sores on the gingiva, gingiva infection, or any contagious gingiva condition

Group 4:


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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seok Hyun Yun

Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seok-Hyun Yun, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jing Zhang, PhD

Role: CONTACT

6173730127

Seok-Hyun Yun, PhD

Role: CONTACT

6177688704

Facility Contacts

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Jing Zhang, PhD

Role: primary

617-373-0127

Seok-Hyun Yun, PhD

Role: backup

6177688704

References

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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.

Reference Type BACKGROUND
PMID: 12719068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18405974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15019316 (View on PubMed)

Other Identifiers

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2023P000338

Identifier Type: -

Identifier Source: org_study_id

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