Keratoconus Detection

This study is currently recruiting participants.
Verified June 2012 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ronald H. Silverman, Columbia University
ClinicalTrials.gov Identifier:
NCT01403129
First received: July 25, 2011
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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. Our aim is to combine measurements of different properties of the cornea to develop means for early detection of KC.


Condition Intervention
Keratoconus
Procedure: Artemis Ultrasound Exam
Procedure: ARFI Ultrasound exam

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Early Detection of Keratoconus

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Differences in elastic parameters between normal and KC corneas. [ Time Frame: Up to 1 year after enrollment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: December 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Keratoconus-Suspect
A person who has or is suspected of having keratoconus.
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.
Other Name: UBM, ultrasound biomicroscope, high frequency ultrasound
Procedure: ARFI Ultrasound exam
Acoustic radiation force ultrasound exam. Corneal tissue displacements at the epithelial surface, at Bowman's membrane, and at the posterior corneal surface will be measured, pre and post toneburst. Measurements will be taken in both eyes.
Keratoconus-Related
A person who is genetically related to someone with keratoconus.
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.
Other Name: UBM, ultrasound biomicroscope, high frequency ultrasound
Procedure: ARFI Ultrasound exam
Acoustic radiation force ultrasound exam. Corneal tissue displacements at the epithelial surface, at Bowman's membrane, and at the posterior corneal surface will be measured, pre and post toneburst. Measurements will be taken in both eyes.
Age-Matched Normal
A person who is approximately the same age as subjects who have been enrolled in the study.
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.
Other Name: UBM, ultrasound biomicroscope, high frequency ultrasound
Procedure: ARFI Ultrasound exam
Acoustic radiation force ultrasound exam. Corneal tissue displacements at the epithelial surface, at Bowman's membrane, and at the posterior corneal surface will be measured, pre and post toneburst. Measurements will be taken in both eyes.

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.

Our 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting to CUMC associated physicians and the London Vision Clinic.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403129

Contacts
Contact: Harriet O Lloyd, MS 2123052703 hl2596@columbia.edu
Contact: Ronald H Silverman, PhD 2123055484 rs3072@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Harriet O Lloyd, MS    212-305-2703    hl2596@columbia.edu   
Principal Investigator: Ronald H Silverman, PhD         
United Kingdom
London Vision Clinic Recruiting
London, England, United Kingdom, W1G 7LA
Contact: Tim Archer    +44 20 7224 1005    info@londonvisionclinic.com   
Principal Investigator: Dan Z Reinstein, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Ronald H Silverman, PhD Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: Ronald H. Silverman, Professor of Ophthalmic Science, Columbia University
ClinicalTrials.gov Identifier: NCT01403129     History of Changes
Other Study ID Numbers: AAAF1497, EY019055
Study First Received: July 25, 2011
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by Columbia University:
keratoconus
keratoconus-suspect
ultrasound exam
acoustic radiation force ultrasound exam

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014