NCT05759780

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Aug 2023Aug 2026

First Submitted

Initial submission to the registry

February 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

August 19, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Last Updated

October 23, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

February 26, 2023

Last Update Submit

October 21, 2025

Conditions

CorneaSkin DiseasesGingival Diseases

Keywords

biomechanicscorneaskingingivaoptical coherence tomographyvibrography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Healthy cornea

EXPERIMENTAL

Optical imaging of the cornea in healthy subjects

Device: Optical imaging of the tissues

Healthy skin

EXPERIMENTAL

Optical imaging of the skin in healthy subjects

Device: Optical imaging of the tissues

Healthy gingiva

EXPERIMENTAL

Optical imaging of the gingiva in healthy subjects

Device: Optical imaging of the tissues

Keratoconus cornea

EXPERIMENTAL

Optical imaging of the cornea in mild and moderate keratoconus

Device: Optical imaging of the tissues

Interventions

Optical imaging of the tissuesDEVICE

OCT vibrography

Healthy corneaHealthy gingivaHealthy skinKeratoconus cornea

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with healthy eyes (age 18 - 75, N = 50)

You may not qualify if:

  • 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:
  • Subjects with healthy skin (age 18 - 75, N = 10)
  • Subjects with open cuts/sores on the skin, skin infection, or any contagious skin condition
  • Group 3:
  • Subjects with healthy gingiva (age 18 - 75, N = 10)
  • Subjects with open cuts/sores on the gingiva, gingiva infection, or any contagious gingiva condition
  • Group 4:
  • Mild or moderate keratoconus subjects (age 18 - 40, N = 20)
  • Subjects with K-max above 60 diopters (Pentacam imaging) are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 12719068BACKGROUND

  • 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.

    PMID: 18405974BACKGROUND

  • 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.

    PMID: 15019316BACKGROUND

MeSH Terms

Conditions

Corneal DiseasesSkin DiseasesGingival Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesSkin and Connective Tissue DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Seok-Hyun Yun, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Zhang, PhD

CONTACT

6173730127jzhang110@mgh.harvard.edu

Seok-Hyun Yun, PhD

CONTACT

6177688704syun@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Dermatology

Study Record Dates

First Submitted

February 26, 2023

First Posted

March 8, 2023

Study Start

August 19, 2023

Primary Completion (Estimated)

August 28, 2026

Study Completion (Estimated)

August 28, 2026

Last Updated

October 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)