Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2010-12-31
2020-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Keratoconus-Suspect
A person who has or is suspected of having keratoconus. Will have either or both Artemis-2 exam and OCT exam.
Artemis Ultrasound Exam
Ultrasound exam of both eyes using an Artemis-2 device. Exam will be performed once. Exam duration is 20 minutes per eye.
Optical Coherence Tomography (OCT) Exam
OCT exam of both eyes. Exam will be performed once, duration is 10. I utes per eye.
Keratoconus-Related
A person who is genetically related to someone with keratoconus. Will have either or both Artemis-2 exam and OCT exam.
Artemis Ultrasound Exam
Ultrasound exam of both eyes using an Artemis-2 device. Exam will be performed once. Exam duration is 20 minutes per eye.
Optical Coherence Tomography (OCT) Exam
OCT exam of both eyes. Exam will be performed once, duration is 10. I utes per eye.
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.
Artemis Ultrasound Exam
Ultrasound exam of both eyes using an Artemis-2 device. Exam will be performed once. Exam duration is 20 minutes per eye.
Optical Coherence Tomography (OCT) Exam
OCT exam of both eyes. Exam will be performed once, duration is 10. I utes per eye.
Interventions
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Artemis Ultrasound Exam
Ultrasound exam of both eyes using an Artemis-2 device. Exam will be performed once. Exam duration is 20 minutes per eye.
Optical Coherence Tomography (OCT) Exam
OCT exam of both eyes. Exam will be performed once, duration is 10. I utes per eye.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
6 Years
65 Years
ALL
Yes
Sponsors
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National Eye Institute (NEI)
NIH
Columbia University
OTHER
Responsible Party
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Ronald H Silverman
Professor of Ophthalmic Science
Principal Investigators
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Ronald H Silverman, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center
New York, New York, United States
London Vision Clinic
London, England, United Kingdom
Countries
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References
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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.
Related Links
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Ronald H. Silverman Homepage
Dan Z. Reinstein Homepage
Other Identifiers
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AAAF1497
Identifier Type: -
Identifier Source: org_study_id
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