OCT Vibrography for Biomechanical Properties of Tissues

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05759780
• Collaborator: Massachusetts Eye and Ear Infirmary (Other)
• Enrollment: 80
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cornea; Skin Diseases; Gingival Diseases	Device: Optical imaging of the tissues	N/A

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. We 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 our 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Feb 28, 2026
• Anticipated Study Completion Date: Feb 28, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 = 10)

Exclusion criteria:

• Subjects with K-max above 55 diopters (Pentacam imaging) are excluded

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• Massachusetts Eye and Ear Infirmary

Investigators

• Principal Investigator: Seok-Hyun Yun, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Seok Hyun Yun, Professor of Dermatology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05759780
• Other Study ID Numbers: 2023P000338
• First Posted: Mar 8, 2023
• Last Update Posted: Mar 8, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seok Hyun Yun, Professor of Dermatology, Massachusetts General Hospital: biomechanics; cornea; skin; gingiva; optical coherence tomography; vibrography
• Additional relevant MeSH terms: Gingival Diseases; Skin Diseases

Study Results

No Results Posted as of Mar 8, 2023