OCT Vibrography for Biomechanical Properties of Tissues

Mass General Brigham

Status: Enrolling

Conditions: Gingival Diseases; Skin Diseases; Cornea

Treatments: Device: Optical imaging of the tissues

Study type: Interventional

Funder types: Other

Identifiers

NCT05759780

2023P000338

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 4 patient groups

Healthy cornea

Experimental group

Description:

Optical imaging of the cornea in healthy subjects

Treatment:

Device: Optical imaging of the tissues

Healthy skin

Experimental group

Description:

Optical imaging of the skin in healthy subjects

Treatment:

Device: Optical imaging of the tissues

Healthy gingiva

Experimental group

Description:

Optical imaging of the gingiva in healthy subjects

Treatment:

Device: Optical imaging of the tissues

Keratoconus cornea

Experimental group

Description:

Optical imaging of the cornea in mild and moderate keratoconus

Treatment:

Device: Optical imaging of the tissues