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/18405974/Actively Recruiting
Led by Massachusetts General Hospital · Updated on 2025-10-23
90
Participants Needed
1
Research Sites
N/A
Total Duration
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
OCT Vibrography for Biomechanical Properties of Tissues
J
Jing Zhang, PhD
S
Seok-Hyun Yun, PhD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Massachusetts General Hospital
Lead Sponsor
Massachusetts Eye and Ear Infirmary
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | OCT Vibrography (Investigational Device) | Pentacam Imaging (Reference Standard) |
|---|---|---|
| What it is | A non-invasive diagnostic device that uses Optical Coherence Tomography (OCT) based vibrography to image and measure biomechanical properties of the cornea, skin, and gingiva. | A routinely used imaging device that uses Scheimpflug tomography (Pentacam) to assess corneal shape, thickness, and posterior elevation for diagnosing keratoconus and other corneal conditions. |
| Role in the study | Tested as the investigational device for diagnostic assessment; all participants undergo this imaging procedure to evaluate biomechanical properties. | Serves as the clinical and protocol reference standard for corneal biomechanics and keratoconus diagnosis. |
| Primary use | Investigation of tissue biomechanical properties, particularly to distinguish between healthy and keratoconus corneas, as well as to obtain measurements from skin and gingiva. | Standard diagnostic tool for identifying keratoconus and evaluating biomechanical and structural properties of the cornea. |
| How it is performed | Participants undergo non-contact OCT imaging in which tissue is gently vibrated to capture biomechanical data; performed in a clinical setting. | A non-contact device takes rotating Scheimpflug images of the cornea with participants seated, measuring corneal thickness, shape, and elevation. |
| Evidence maturity | Currently under clinical investigation for diagnostic accuracy and safety; no published patient outcome results are yet available. | Published evidence supports Pentacam’s high sensitivity and specificity in identifying keratoconus; its clinical performance is well-established. |
| Important limitations | As an investigational device, its real-world diagnostic accuracy, ease of use, and patient comfort are still being evaluated. It is not yet proven in larger or more diverse patient populations. | Pentacam requires experienced operators for best results and may not reliably measure in very advanced or severely opaque corneas. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
Have more questions? Get in touch with our team for quick support
Ugo de Sanctis, Carlotta Loiacono, Lorenzo Richiardi...
https://pubmed.ncbi.nlm.nih.gov/18405974/Xiaohui Li, Yaron S Rabinowitz, Karim Rasheed...
https://pubmed.ncbi.nlm.nih.gov/15019316/Gregor Wollensak, Eberhard Spoerl, Theo Seiler
https://pubmed.ncbi.nlm.nih.gov/12719068/Massachusetts General Hospital
Lead Sponsor
Massachusetts Eye and Ear Infirmary
Collaborating Sponsor