Measuring the biomechanical properties of tissues using OCT Vibrography
A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues
This study is testing a new way to measure how stretchy and firm different human tissues are, especially looking at the differences between healthy eyes and those with keratoconus, to help improve diagnosis and treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05759780 on ClinicalTrials.gov |
What this trial studies
This study aims to develop OCT Vibrography, also known as OCT elastography, as a new method for assessing the biomechanical properties of human tissues in vivo. The researchers will establish baseline data from healthy subjects and compare the elastic moduli of different tissue types, particularly focusing on keratoconus versus normal eyes. The findings could enhance the understanding of how tissue microstructure relates to its mechanical properties, potentially improving the diagnosis and treatment of conditions like keratoconus and inflammatory skin and gingival diseases. The technology may also have broader applications beyond the specific tissues studied.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals aged 18-75 and those aged 18-40 with mild to moderate keratoconus.
Not a fit: Patients with severe keratoconus or those with a history of eye diseases or skin infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment options for patients with keratoconus and inflammatory skin and gingival diseases.
How similar studies have performed: Other studies have shown promise in using similar optical imaging techniques for assessing tissue properties, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Seok-Hyun Yun, PhD — Massachusetts General Hospital
- Study coordinator: Jing Zhang, PhD
- Email: jzhang110@mgh.harvard.edu
- Phone: 6173730127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.