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NCT Number: NCT05759780

OCT Vibrography for 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical imaging of the tissues

Device

OCT vibrography

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Zhang, PhD

CONTACT

[email protected]

6173730127

Seok-Hyun Yun, PhD

CONTACT

[email protected]

6177688704

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Massachusetts Eye and Ear Infirmary

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2023
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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