Keratoconus Detection by Ultrasound

August 2, 2021 updated by: Ronald H Silverman, Columbia University

Early Detection of Keratoconus Using Ultrasound

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.

Study Overview

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

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • England
      • London, England, United Kingdom, W1G 7LA
        • London Vision Clinic
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Ultrasound biomicroscope (UBM)
  • High frequency ultrasound
OCT exam of both eyes. Exam will be performed once, duration is 10. I utes per eye.
Other Names:
  • OCT
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:
  • Ultrasound biomicroscope (UBM)
  • High frequency ultrasound
OCT exam of both eyes. Exam will be performed once, duration is 10. I utes per eye.
Other Names:
  • OCT
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:
  • Ultrasound biomicroscope (UBM)
  • High frequency ultrasound
OCT exam of both eyes. Exam will be performed once, duration is 10. I utes per eye.
Other Names:
  • OCT

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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

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)?

No

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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