Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05759780

Conditions

Cornea

Skin Diseases

Gingival Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Optical imaging of the tissues

Study Details

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.

Conditions

Cornea

Skin Diseases

Gingival Diseases

Study ID

NCT05759780

Start date

Aug 19, 2023

Status verified date

Oct, 2026

Completion date

Aug 28, 2030

Anticipated

Primary completion date

Aug 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Healthy cornea

Optical imaging of the cornea in healthy subjects

experimental: Healthy skin

Optical imaging of the skin in healthy subjects

experimental: Healthy gingiva

Optical imaging of the gingiva in healthy subjects

experimental: Keratoconus cornea

Optical imaging of the cornea in mild and moderate keratoconus

Interventions

Optical imaging of the tissues

OCT vibrography

Primary outcome measure

  • Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Jing Zhang, PhD

6173730127jzhang110@mgh.harvard.edu

Seok-Hyun Yun, PhD

6177688704syun@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jing Zhang, PhD

6173730127jzhang110@mgh.harvard.edu

Seok-Hyun Yun, PhD

6177688704syun@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.