Keratoconus Detection by Ultrasound

Keratoconus Clinical Trial

Official title:

Early Detection of Keratoconus Using Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403129
• Other study ID #: AAAF1497
• Secondary ID: R01EY019055
• Status: Completed
• Start date: December 2010
• Est. completion date: January 2020

Study information

• Verified date: August 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United Kingdom	London Vision Clinic	London	England
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Eye Institute (NEI)

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (7)

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/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.2015.07.0 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Dan Z. Reinstein Homepage
•   Ronald H. Silverman Homepage