Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus.
Gregor Wollensak, Eberhard Spoerl, Theo Seiler
https://pubmed.ncbi.nlm.nih.gov/12719068Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID05759780
A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues
Led by Massachusetts General Hospital · Updated on 2025-10-23
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
M
Massachusetts Eye and Ear Infirmary
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating OCT Vibrography, also known as OCT elastography, as a new technique to measure the biomechanical properties of human tissues like the cornea, skin, and gingiva. The study aims to establish baseline data in healthy individuals, compare tissue elasticity, and investigate differences between normal eyes and those affected by keratoconus. This research could improve understanding of tissue structure and support better diagnosis and treatment of keratoconus and inflammatory skin and gingival diseases. Participants will undergo optical imaging of their cornea, skin, or gingiva using the OCT Vibrography device. The study includes healthy volunteers as well as participants with mild to moderate keratoconus. Different groups will have their tissues imaged to collect data on elastic properties. The study is randomized and involves no masking or blinding. During the study, researchers will monitor participants for any serious unexpected problems related to the device use over one year. Participants will receive assessments involving optical imaging, and their data will help measure tissue elasticity. The total participation duration varies by individual, with safety and feasibility as key outcomes. The study is sponsored by Massachusetts General Hospital and is open to adults aged 18 to 75 years.
CONDITIONS
Brief Title
OCT Vibrography for Biomechanical Properties of Tissues
Who Can Participate
Age: 18Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Subjects with healthy eyes aged 18 to 75 years
- Subjects with healthy skin aged 18 to 75 years
- Subjects with healthy gingiva aged 18 to 75 years
- Subjects with mild or moderate keratoconus aged 18 to 40 years
You will not qualify if you...
- History of eye diseases or previous eye surgeries
- Diagnosis of diabetes or family history of glaucoma
- Allergy to anesthetic eyedrops, especially proparacaine
- Severe allergies
- Difficulty biting
- Recurrent corneal erosion
- Open cuts, sores, infections, or contagious conditions on skin
- Open cuts, sores, infections, or contagious conditions on gingiva
- Keratoconus subjects with K-max above 60 diopters (Pentacam imaging)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Implementation
Duration - 1 day
Participants undergo optical imaging of tissues using OCT Vibrography to measure biomechanical properties of the cornea, skin, or gingiva.
1 visit (in-person) for OCT Vibrography imaging
Long-term Monitoring
Duration - Up to 1 year
Participants are observed for up to 1 year to monitor for any adverse events related to the application of the OCT Vibrography device.
Periodic follow-up contacts or visits as needed
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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Research Team
J
Jing Zhang, PhD
S
Seok-Hyun Yun, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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Published Research Related To This Trial
Sensitivity and specificity of posterior corneal elevation measured by Pentacam in discriminating keratoconus/subclinical keratoconus.
Ugo de Sanctis, Carlotta Loiacono, Lorenzo Richiardi...
https://pubmed.ncbi.nlm.nih.gov/18405974Longitudinal study of the normal eyes in unilateral keratoconus patients.
Xiaohui Li, Yaron S Rabinowitz, Karim Rasheed...
https://pubmed.ncbi.nlm.nih.gov/15019316