Keratoconus Detection by Ultrasound

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Keratoconus

Clinical Trial Details

NCT number	NCT01403129
Study type	Observational
Source	Columbia University
Contact
Status	Completed
Phase
Start date	December 2010
Completion date	January 2020

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.