Dynamic Light Scattering and Keratoscopy for Corneal Examination
Primary Purpose
Corneal Diseases
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Corneal Diseases focused on measuring Normal Volunteers, Dynamic Light Scattering (DLS), Corneal Opacities, Cornea, Transparency, Vision
Eligibility 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.
Sites / Locations
- National Eye Institute (NEI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00050466
First Posted
December 9, 2002
Last Updated
March 3, 2008
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00050466
Brief Title
Dynamic Light Scattering and Keratoscopy for Corneal Examination
Official Title
A Pilot Study Using the Dynamic Light Scattering Device (DLS) Combined With Keratoscopy on the Cornea in Vivo
Study Type
Observational
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Diseases
Keywords
Normal Volunteers, Dynamic Light Scattering (DLS), Corneal Opacities, Cornea, Transparency, Vision
7. Study Design
Enrollment
24 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
National Eye Institute (NEI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11878822
Citation
Datiles MB 3rd, Ansari RR, Reed GF. A clinical study of the human lens with a dynamic light scattering device. Exp Eye Res. 2002 Jan;74(1):93-102. doi: 10.1006/exer.2001.1106.
Results Reference
background
PubMed Identifier
3427992
Citation
Benedek GB, Chylack LT Jr, Libondi T, Magnante P, Pennett M. Quantitative detection of the molecular changes associated with early cataractogenesis in the living human lens using quasielastic light scattering. Curr Eye Res. 1987 Dec;6(12):1421-32. doi: 10.3109/02713688709044506.
Results Reference
background
PubMed Identifier
9088735
Citation
Thurston GM, Hayden DL, Burrows P, Clark JI, Taret VG, Kandel J, Courogen M, Peetermans JA, Bowen MS, Miller D, Sullivan KM, Storb R, Stern H, Benedek GB. Quasielastic light scattering study of the living human lens as a function of age. Curr Eye Res. 1997 Mar;16(3):197-207. doi: 10.1076/ceyr.16.3.197.15410.
Results Reference
background
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Dynamic Light Scattering and Keratoscopy for Corneal Examination
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