Clinical trial NCT05759780: OCT Vibrography for Biomechanical Properties of Tissues
Official title: A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cornea
Skin Diseases
Gingival Diseases
Keywords: biomechanics
cornea
skin
gingiva
optical coherence tomography
vibrography
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Eye and Ear Infirmary
First posted: 2023-03-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Seok-Hyun Yun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.