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RecruitingNCT05759780Updated Oct 13, 2026

OCT Vibrography for Biomechanical Properties of Tissues

An interventional study of Optical imaging of the tissues in Cornea, Skin Diseases and Gingival Diseases, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Updated Oct 13, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cornea
  • Skin Diseases
  • Gingival Diseases

Keywords

  • biomechanics
  • cornea
  • skin
  • gingiva
  • optical coherence tomography
  • vibrography
03

In context

Corneal Diseases

219 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.

This study's planned enrollment of 90 is above the median of 40 across 132 interventional studies indexed under Corneal Diseases.

Browse Corneal Diseases studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Healthy cornea

    Optical imaging of the cornea in healthy subjects

    Device: Optical imaging of the tissues

  • Experimental
    Healthy skin

    Optical imaging of the skin in healthy subjects

    Device: Optical imaging of the tissues

  • Experimental
    Healthy gingiva

    Optical imaging of the gingiva in healthy subjects

    Device: Optical imaging of the tissues

  • Experimental
    Keratoconus cornea

    Optical imaging of the cornea in mild and moderate keratoconus

    Device: Optical imaging of the tissues

Interventions

  • DeviceOptical imaging of the tissues

    OCT vibrography

06

What researchers measure

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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 12719068 ↗
  • 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. PubMed 18405974 ↗
  • 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. PubMed 15019316 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Aug 28, 2026→Aug 28, 2030
Oct 13, 2026
Study completion
Aug 28, 2026→Aug 28, 2030
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Primary completion Aug 28, 2026→Aug 28, 2030
    Study completion Aug 28, 2026→Aug 28, 2030
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05759780
Responsible party
Seok Hyun Yun (Professor of Dermatology, Massachusetts General Hospital) — Principal investigator
First posted
Mar 8, 2023
Start date
Aug 19, 2023
Primary completion
Aug 28, 2030 (estimated)
Completion
Aug 28, 2030 (estimated)
Last update
Oct 13, 2026

Study contacts

Jing Zhang, PhD
Contact
jzhang110@mgh.harvard.edu
6173730127
Seok-Hyun Yun, PhD
Contact
syun@mgh.harvard.edu
6177688704
Seok-Hyun Yun, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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