Keratoconus Detection by Ultrasound
Early Detection of Keratoconus Using Ultrasound
2 other identifiers
observational
250
2 countries
2
Brief Summary
Keratoconus (KC) is a corneal disease which will in many cases ultimately require corneal transplantation to maintain vision. Early detection, which is not possible with current technology, would allow early treatment and prevent severe damage to KC corneas inadvertently operated upon for correction of vision. The investigators' aim is to combine measurements of different properties of the cornea to develop means for early detection of KC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 25, 2011
CompletedFirst Posted
Study publicly available on registry
July 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedAugust 3, 2021
August 1, 2021
9.1 years
July 25, 2011
August 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences in elastic parameters between normal and KC corneas.
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.
Up to 1 year after enrollment
Study Arms (3)
Keratoconus-Suspect
A person who has or is suspected of having keratoconus. Will have either or both Artemis-2 exam and OCT exam.
Keratoconus-Related
A person who is genetically related to someone with keratoconus. Will have either or both Artemis-2 exam and OCT exam.
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.
Interventions
Ultrasound exam of both eyes using an Artemis-2 device. Exam will be performed once. Exam duration is 20 minutes per eye.
OCT exam of both eyes. Exam will be performed once, duration is 10. I utes per eye.
Eligibility Criteria
Patients presenting to CUMC associated physicians and the London Vision Clinic.
You may qualify if:
- 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
You may not qualify if:
- Other eye disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Eye Institute (NEI)collaborator
Study Sites (2)
Columbia University Medical Center
New York, New York, 10032, United States
London Vision Clinic
London, England, W1G 7LA, United Kingdom
Related Publications (7)
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.
PMID: 25063407RESULTSilverman 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.
PMID: 24557351RESULTUrsea 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.
PMID: 23205905RESULTUrs 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.
PMID: 26948783RESULTReinstein 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.
PMID: 26544561RESULTReinstein 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.
PMID: 26186562RESULTSilverman 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.
PMID: 27515569RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald H Silverman, PhD
Columbia University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Ophthalmic Science
Study Record Dates
First Submitted
July 25, 2011
First Posted
July 27, 2011
Study Start
December 1, 2010
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
August 3, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share