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OpenTrials
Completed

NCT Number: NCT01403129

Keratoconus Detection by 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.

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Key information

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

London Vision Clinic, London, England, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artemis Ultrasound Exam

Procedure

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

Optical Coherence Tomography (OCT) Exam

Procedure

OCT exam of both eyes. Exam will be performed once, duration is 10. I utes per eye.

Other names: OCT

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Early Detection of Keratoconus Using Ultrasound

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2011
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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