Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001617
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Test of QLS Device to Detect Early Cataracts
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Feasibility Study - Use of Quasielastic Light Scattering QLS Device in a Study of the Human Lens and Lens Opacities
Status:
COMPLETED
Status Verified Date:
1999-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the reliability of an instrument called the Quasi Elastic Laser Scattering Device QLS in detecting early changes in cataract formation
Surgery is currently the only treatment for cataracts Many laboratories however are researching drugs to reverse delay or prevent cataract formation Anti-cataract drugs presumably would be most effective given early in the course of disease When clinical trials of these drugs are begun dependable and standardized methods for documenting and monitoring lens opacities will be needed to test their effectiveness The QLS was designed to detect the earliest molecular changes in cataract development This study will evaluate the usefulness and reliability of this instrument in measuring these changes
Normal volunteers and patients with cataracts in this study will have a standard eye examination including a vision test and eye pressure measurement The pupils will be dilated for QLS testing and for examination of the retina Photographs of the retina may be taken The QLS test uses a very dim laser light similar to that used to scan grocery items in the supermarket The laser beam is projected into the lens of the eye and the scattered light is collected and analyzed to determine normal and abnormal molecular interactions in the lens Two measurements will be done for each eye The test will be repeated in 6 months to determine reproducibility of the system
Surgery is currently the only treatment for cataracts Many laboratories however are researching drugs to reverse delay or prevent cataract formation Anti-cataract drugs presumably would be most effective given early in the course of disease When clinical trials of these drugs are begun dependable and standardized methods for documenting and monitoring lens opacities will be needed to test their effectiveness The QLS was designed to detect the earliest molecular changes in cataract development This study will evaluate the usefulness and reliability of this instrument in measuring these changes
Normal volunteers and patients with cataracts in this study will have a standard eye examination including a vision test and eye pressure measurement The pupils will be dilated for QLS testing and for examination of the retina Photographs of the retina may be taken The QLS test uses a very dim laser light similar to that used to scan grocery items in the supermarket The laser beam is projected into the lens of the eye and the scattered light is collected and analyzed to determine normal and abnormal molecular interactions in the lens Two measurements will be done for each eye The test will be repeated in 6 months to determine reproducibility of the system
Detailed Description:
Recently a device has been created to determine molecular interactions that occur in the nucleus of the lens called Quasi Elastic Laser Scattering Device QLS Preliminary studies have shown its potential in the detection of the earliest changes occurring in cataract at the stage where anticataract treatment would theoretically be most effective in reversing delaying or preventing cataracts A new miniaturized version of this device has been developed by NASA using low energy lasers and offered for further development and testing at the NEI We therefore propose to conduct a preliminary study to evaluate the usefulness and reproducibility of this instrument for quantitating lens changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-EI-0183 | None | None | None |