OCT Vibrography for Biomechanical Properties of Tissues

Skin Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759780
• Other study ID #: 2023P000338
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2023
• Est. completion date: August 28, 2026

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Xu Feng, PhD
• Phone: 6177246798
• Email: xfeng4[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 28, 2026
• Est. primary completion date: August 28, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cornea
• Gingival Diseases
• Skin Diseases

Intervention

Device:
• Optical imaging of the tissues
OCT vibrography

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.	Frequency and severity of all treatment-related adverse events	1 year