CorneaNCT05759780
OCT Vibrography for Biomechanical Properties of Tissues
A study testing Optical imaging of the tissues in people with Cornea and Skin Diseases, run by Massachusetts General Hospital at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cornea, Skin Diseases, Gingival Diseases
- What is being tested?
- Optical imaging of the tissues
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2023to 28 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with healthy eyes (age 18 - 75, N = 50)
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jing Zhang, PhD, 6173730127, jzhang110@mgh.harvard.edu
Seok-Hyun Yun, PhD, 6177688704, syun@mgh.harvard.edu
About this study
Official title: A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues
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.
- Conditions
- Cornea, Skin Diseases, Gingival Diseases
- Being tested
- Optical imaging of the tissues
- Keywords
- biomechanics, cornea, skin, gingiva, optical coherence tomography, vibrography
- Medical subject headings
- Corneal Diseases, Skin Diseases, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical imaging of the tissuesDevice
OCT vibrography
| Study group | Role | What they receive |
|---|---|---|
| Healthy cornea | Experimental | Optical imaging of the cornea in healthy subjects Receives: Device: Optical imaging of the tissues |
| Healthy skin | Experimental | Optical imaging of the skin in healthy subjects Receives: Device: Optical imaging of the tissues |
| Healthy gingiva | Experimental | Optical imaging of the gingiva in healthy subjects Receives: Device: Optical imaging of the tissues |
| Keratoconus cornea | Experimental | Optical imaging of the cornea in mild and moderate keratoconus Receives: Device: Optical imaging of the tissues |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start19 Aug 2023
- Primary completion28 Aug 2030 (estimated)
- Study completion28 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CorneaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary
- Responsible party
- Principal investigator, Seok Hyun Yun, Massachusetts General Hospital
- Investigators
- Seok-Hyun Yun, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759780
- Sponsor's protocol ID
- 2023P000338
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 12719068de 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 18405974Li 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues
- ClinicalTrials.gov ID
- NCT05759780
- Acronym / sponsor ID
- 2023P000338
- Conditions
- Cornea, Skin Diseases, Gingival Diseases
- Keywords
- biomechanics, cornea, skin, gingiva, optical coherence tomography, vibrography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary
- Study start
- 19 Aug 2023 (actual)
- Primary completion
- 28 Aug 2030 (estimated)
- Study completion
- 28 Aug 2030 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy cornea | Experimental | Device: Optical imaging of the tissuesOptical imaging of the cornea in healthy subjects |
| Healthy skin | Experimental | Device: Optical imaging of the tissuesOptical imaging of the skin in healthy subjects |
| Healthy gingiva | Experimental | Device: Optical imaging of the tissuesOptical imaging of the gingiva in healthy subjects |
| Keratoconus cornea | Experimental | Device: Optical imaging of the tissuesOptical imaging of the cornea in mild and moderate keratoconus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with healthy eyes (age 18 - 75, N = 50)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical imaging of the tissuesOCT vibrography | Device | Healthy cornea, Healthy gingiva, Healthy skin, Keratoconus cornea |
Primary outcome
Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.
Time frame: 1 year
Frequency and severity of all treatment-related adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 12719068Wollensak 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.
- Background: PubMed 18405974de 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.
- Background: PubMed 15019316Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seok-Hyun Yun, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical imaging of the tissues in people with Cornea and Skin Diseases, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhang, PhD (6173730127, jzhang110@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05759780, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.