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| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 9, 2002 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | December 2002 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00050466 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Dynamic Light Scattering and Keratoscopy for Corneal Examination |
| Official Title ICMJE | A Pilot Study Using the Dynamic Light Scattering Device (DLS) Combined With Keratoscopy on the Cornea in Vivo |
| 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. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE | Corneal Diseases |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 24 |
| Completion Date | September 2005 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00050466 |
| Responsible Party | |
| Study ID Numbers ICMJE | 030012, 03-EI-0012 |
| Study Sponsor ICMJE | National Eye Institute (NEI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | September 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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