- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01403129
Keratoconus Detection by Ultrasound
Early Detection of Keratoconus Using Ultrasound
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Keratoconus is the most common degenerative disease affecting the cornea. As keratoconus develops, the cornea thins and bulges. Eventually, a corneal transplant may be needed to maintain vision. In its earliest stages, the disease is particularly difficult to detect. This is of great importance to the corneal refractive surgeon because surgical treatment of a keratoconic cornea will weaken it and greatly accelerate the occurrence of symptoms. Early detection of keratoconus will benefit patients because of the recent development of methods for strengthening the corneal stroma and preventing disease progression.
The investigators have developed a technique based on the use of high resolution ultrasound for imaging the cornea and measuring the thickness of its component layers, including the epithelium and the stroma. In early keratoconus, as the anterior stromal surface begins to bulge forward, the epithelium will thin above the apex of the bulge and thicken around it, to maintain a smooth anterior surface. The investigators have also developed methods for characterizing the elastic properties of the cornea by inducing and measuring surface displacements in response to a pulse of acoustic radiation force.
The investigators' goal is to reduce the percentage of screened cases deemed keratoconus-suspect by at least a factor of two by allowing an unambiguous diagnosis of early keratoconus. This would provide two major benefits; (1) to be able to predict eyes with higher risk of developing ectasia after corneal refractive surgery, and (2) early diagnosis would allow earlier treatment of the condition with collagen crosslinking, preserving the cornea from disease progression.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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England
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London, England, United Kingdom, W1G 7LA
- London Vision Clinic
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis of keratoconus (KC) or keratoconus-suspect
- Blood relation of person with KC
- Age-matched normal of KC subjects
- Ability to sit still in front of ultrasound unit and lie on exam table
Exclusion Criteria:
- Other eye disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Keratoconus-Suspect
A person who has or is suspected of having keratoconus.
Will have either or both Artemis-2 exam and OCT exam.
|
Ultrasound exam of both eyes using an Artemis-2 device.
Exam will be performed once.
Exam duration is 20 minutes per eye.
Other Names:
OCT exam of both eyes.
Exam will be performed once, duration is 10.
I utes per eye.
Other Names:
|
Keratoconus-Related
A person who is genetically related to someone with keratoconus.
Will have either or both Artemis-2 exam and OCT exam.
|
Ultrasound exam of both eyes using an Artemis-2 device.
Exam will be performed once.
Exam duration is 20 minutes per eye.
Other Names:
OCT exam of both eyes.
Exam will be performed once, duration is 10.
I utes per eye.
Other Names:
|
Age-Matched Normal
A person who is approximately the same age as subjects who have been enrolled in the study. Will have either or both Artemis-2 exam and OCT exam. |
Ultrasound exam of both eyes using an Artemis-2 device.
Exam will be performed once.
Exam duration is 20 minutes per eye.
Other Names:
OCT exam of both eyes.
Exam will be performed once, duration is 10.
I utes per eye.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in elastic parameters between normal and KC corneas.
Time Frame: Up to 1 year after enrollment
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The undamped vibrational frequency and damping time-constant for the anterior and posterior corneal surfaces and for Bowman's membrane will be measured.
The elastic modulus will be calculated form the change in corneal thickness resulting from known radiation force.
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Up to 1 year after enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Urs R, Lloyd HO, Silverman RH. Acoustic radiation force for noninvasive evaluation of corneal biomechanical changes induced by cross-linking therapy. J Ultrasound Med. 2014 Aug;33(8):1417-26. doi: 10.7863/ultra.33.8.1417.
- Silverman RH, Urs R, Roychoudhury A, Archer TJ, Gobbe M, Reinstein DZ. Epithelial remodeling as basis for machine-based identification of keratoconus. Invest Ophthalmol Vis Sci. 2014 Mar 13;55(3):1580-7. doi: 10.1167/iovs.13-12578.
- Ursea R, Feng M, Urs R, RoyChoudhury A, Silverman RH. Comparison of artemis 2 ultrasound and Visante optical coherence tomography corneal thickness profiles. J Refract Surg. 2013 Jan;29(1):36-41. doi: 10.3928/1081597X-20121126-01. Epub 2012 Nov 30.
- Urs R, Lloyd HO, Reinstein DZ, Silverman RH. Comparison of very-high-frequency ultrasound and spectral-domain optical coherence tomography corneal and epithelial thickness maps. J Cataract Refract Surg. 2016 Jan;42(1):95-101. doi: 10.1016/j.jcrs.2015.07.038.
- Reinstein DZ, Archer TJ, Urs R, Gobbe M, RoyChoudhury A, Silverman RH. Detection of Keratoconus in Clinically and Algorithmically Topographically Normal Fellow Eyes Using Epithelial Thickness Analysis. J Refract Surg. 2015 Nov;31(11):736-44. doi: 10.3928/1081597X-20151021-02.
- Reinstein DZ, Yap TE, Archer TJ, Gobbe M, Silverman RH. Comparison of Corneal Epithelial Thickness Measurement Between Fourier-Domain OCT and Very High-Frequency Digital Ultrasound. J Refract Surg. 2015 Jul;31(7):438-45. doi: 10.3928/1081597X-20150623-01.
- Silverman RH, Urs R, RoyChoudhury A, Archer TJ, Gobbe M, Reinstein DZ. Combined tomography and epithelial thickness mapping for diagnosis of keratoconus. Eur J Ophthalmol. 2017 Mar 10;27(2):129-134. doi: 10.5301/ejo.5000850. Epub 2016 Aug 8.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAF1497
- R01EY019055 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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