OCT Vibrography for Biomechanical Properties of Tissues
NCT ID: NCT05759780
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-08-19
2026-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Healthy cornea
Optical imaging of the cornea in healthy subjects
Optical imaging of the tissues
OCT vibrography
Healthy skin
Optical imaging of the skin in healthy subjects
Optical imaging of the tissues
OCT vibrography
Healthy gingiva
Optical imaging of the gingiva in healthy subjects
Optical imaging of the tissues
OCT vibrography
Keratoconus cornea
Optical imaging of the cornea in mild and moderate keratoconus
Optical imaging of the tissues
OCT vibrography
Interventions
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Optical imaging of the tissues
OCT vibrography
Eligibility Criteria
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Inclusion Criteria
• Subjects with healthy skin (age 18 - 75, N = 10)
• Subjects with healthy gingiva (age 18 - 75, N = 10)
• Mild or moderate keratoconus subjects (age 18 - 40, N = 20)
Exclusion Criteria
* 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:
• Subjects with open cuts/sores on the skin, skin infection, or any contagious skin condition
Group 3:
• Subjects with open cuts/sores on the gingiva, gingiva infection, or any contagious gingiva condition
Group 4:
• Subjects with K-max above 60 diopters (Pentacam imaging) are excluded
18 Years
75 Years
ALL
Yes
Sponsors
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Massachusetts Eye and Ear Infirmary
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Seok Hyun Yun
Professor of Dermatology
Principal Investigators
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Seok-Hyun Yun, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2023P000338
Identifier Type: -
Identifier Source: org_study_id
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