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Dynamic Light Scattering and Keratoscopy for Corneal Examination
This study has been completed.
Sponsored by: National Eye Institute (NEI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00050466
  Purpose

This pilot study will examine the usefulness of a new instrument called the Dynamic Light Scattering (DLS) device for documenting and monitoring changes in the cornea, the front part of the eye where contact lenses are placed. The DLS device uses a low-intensity laser similar to that used in supermarket checkouts to measure the cloudiness of the cornea. The results of this study may lead to further investigations using DLS to discover the cause of corneal clouding and to develop treatments to prevent it.

Healthy volunteers and patients with corneal clouding or opacification 18 years of age and older may be eligible for this study.

Participants will have a standard eye examination, including a check of visual acuity and eye pressure. The retina will also be examined and photographs of the cornea may be taken. For the DLS test, the subject sits in front of the device and looks at a yellow-green target while the cloudiness of the cornea is measured. Subjects will be tested four times. The entire procedure takes less than 30 minutes.


Condition
Corneal Diseases

U.S. FDA Resources
Study Type: Observational
Official Title: A Pilot Study Using the Dynamic Light Scattering Device (DLS) Combined With Keratoscopy on the Cornea in Vivo

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 24
Study Start Date: December 2002
Estimated Study Completion Date: September 2005
Detailed Description:

Corneal disease and injuries are the leading cause of visits to eye care clinics in the US today. These diseases are also some of the most painful eye disorders. Two important areas for research on the cornea are 1) to explore and understand the molecular basis of corneal transparency and 2) to analyze the molecular nature of corneal inflammation and wound healing. We have developed a new clinical device to understand molecular changes that occur in the lens, called Dynamic Light Scattering (DLS) device. Studies have shown its potential in the detection of the earliest changes occurring in the cataract, and have also shown good test retest reproducibility of the system. We now would like to apply this technique to study changes that occur in corneal opacification. In this pilot project, we would like to study the normal cornea in young and older persons (volunteers) as well as cloudy, opaque corneas. This will allow us to determine if useful data can be obtained, and if so, lead to further studies in various corneal disorders caused by trauma, infections, and dystrophies, as well as those caused by systemic or inherited disorders.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

Individuals greater than or equal to 18 years of age.

Controls:

Control subjects must have normal, clear corneas as determined by slit lamp biomicroscopy and central corneal thickness less than 0.55 mm centrally.

Patients:

Patients with corneal clouding and opacification.

EXCLUSION CRITERIA:

To be eligible, participants must not satisfy the criterion below:

Individuals who cannot cooperate or keep still for the DLS measurements.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050466

Locations
United States, Maryland
National Eye Institute (NEI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 030012, 03-EI-0012
Study First Received: December 9, 2002
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00050466  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Normal Volunteers
Dynamic Light Scattering (DLS)
Corneal Opacities
Cornea
Transparency
Vision

Study placed in the following topic categories:
Corneal Diseases
Eye Diseases
Corneal Opacity

ClinicalTrials.gov processed this record on January 15, 2009