OCT Vibrography for Biomechanical Properties of Tissues

Not Applicable

Recruiting

• Conditions: Cornea; Gingival Diseases; Skin Diseases
• Interventions: Device: Optical imaging of the tissues

• Registration Number: NCT05759780
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2023-02-26
• Study First Submitted QC: 2023-02-26
• Study First Posted: 2023-03-08
• Study Start: 2023-08-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2026-08-28
• Study Completion: 2026-08-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Keratoconus cornea	Optical imaging of the tissues	Optical imaging of the cornea in mild and moderate keratoconus
Healthy cornea	Optical imaging of the tissues	Optical imaging of the cornea in healthy subjects
Healthy skin	Optical imaging of the tissues	Optical imaging of the skin in healthy subjects
Healthy gingiva	Optical imaging of the tissues	Optical imaging of the gingiva in healthy subjects

Primary Outcome Measures

Name	Time	Method
Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.	1 year	Frequency and severity of all treatment-related adverse events

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States