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| Name | Class |
|---|---|
| Massachusetts Eye and Ear Infirmary | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy cornea | Experimental | Optical imaging of the cornea in healthy subjects |
|
| Healthy skin | Experimental | Optical imaging of the skin in healthy subjects |
|
| Healthy gingiva | Experimental | Optical imaging of the gingiva in healthy subjects |
|
| Keratoconus cornea | Experimental | Optical imaging of the cornea in mild and moderate keratoconus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical imaging of the tissues | Device | OCT vibrography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Group 1:
Inclusion criteria:
• Subjects with healthy eyes (age 18 - 75, N = 50)
Exclusion criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Zhang, PhD | Contact | 6173730127 | jzhang110@mgh.harvard.edu | |
| Seok-Hyun Yun, PhD | Contact | 6177688704 | syun@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Seok-Hyun Yun, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12719068 | Background | 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. | |
| 18405974 | Background | 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. |
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| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D012871 | Skin Diseases |
| D005882 | Gingival Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| 15019316 | Background | 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. |
| D009057 |
| Stomatognathic Diseases |