Back to resultsOCT Vibrography for Biomechanical Properties of Tissues
Primary Purpose
Cornea, Skin Diseases, Gingival Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical imaging of the tissues
Sponsored by
About this trial
This is an interventional basic science trial for Cornea focused on measuring biomechanics, cornea, skin, gingiva, optical coherence tomography, vibrography
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 = 10) Exclusion criteria: • Subjects with K-max above 55 diopters (Pentacam imaging) are excluded
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Healthy cornea
Healthy skin
Healthy gingiva
Keratoconus cornea
Arm Description
Optical imaging of the cornea in healthy subjects
Optical imaging of the skin in healthy subjects
Optical imaging of the gingiva in healthy subjects
Optical imaging of the cornea in mild and moderate keratoconus
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05759780
First Posted
February 26, 2023
Last Updated
August 9, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Eye and Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT05759780
Brief Title
OCT Vibrography for Biomechanical Properties of Tissues
Official Title
A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 5, 2023 (Anticipated)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Eye and Ear Infirmary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cornea, Skin Diseases, Gingival Diseases
Keywords
biomechanics, cornea, skin, gingiva, optical coherence tomography, vibrography
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy cornea
Arm Type
Experimental
Arm Description
Optical imaging of the cornea in healthy subjects
Arm Title
Healthy skin
Arm Type
Experimental
Arm Description
Optical imaging of the skin in healthy subjects
Arm Title
Healthy gingiva
Arm Type
Experimental
Arm Description
Optical imaging of the gingiva in healthy subjects
Arm Title
Keratoconus cornea
Arm Type
Experimental
Arm Description
Optical imaging of the cornea in mild and moderate keratoconus
Intervention Type
Device
Intervention Name(s)
Optical imaging of the tissues
Intervention Description
OCT vibrography
Primary Outcome Measure Information:
Title
Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.
Description
Frequency and severity of all treatment-related adverse events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 = 10)
Exclusion criteria:
• Subjects with K-max above 55 diopters (Pentacam imaging) are excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Feng, PhD
Phone
6177246798
Email
xfeng4@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Wonjoon Moon, DDS, PhD
Phone
6177246798
Email
wmoon2@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok-Hyun Yun, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Feng, PhD
Phone
617-724-6798
Email
xfeng4@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Wonjoon Moon, DDS, PhD
Phone
6177246798
Email
wmoon2@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Seok-Hyun Yun, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12719068
Citation
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.
Results Reference
background
PubMed Identifier
18405974
Citation
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.
Results Reference
background
PubMed Identifier
15019316
Citation
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.
Results Reference
background
Learn more about this trial
OCT Vibrography for Biomechanical Properties of Tissues
We'll reach out to this number within 24 hrs