Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081991
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-04-28
Brief Title:
Dynamic Light Scattering for Studying Lens Aging and Cataract Formation
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Cross Sectional Clinical Study of Human Lens Aging and Cataract Formation in Vivo Using Dynamic Light Scattering DLS
Status:
COMPLETED
Status Verified Date:
2005-04
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 use dynamic light scattering DLS technology to study normal lens aging and early cataract formation Cataract is a clouding of the lens that interferes with the passage of light to the retina impairing visual acuity DLS uses a low intensity laser light similar to that used in supermarket checkouts to measure lens cloudiness It detects changes in the human lens at the earliest molecular stages of cataract development when anti-cataract treatment would be most effective in reversing delaying or preventing cataract formation
Healthy normal volunteers and patients with age-related cataract between 18 and 80 years of age may be eligible for this study Participants undergo the following tests and procedures
Medical history
Eye examination including the following
Measurement of visual acuity vision chart
Measurement of eye pressure
Dilation of the pupils for slit lamp microscope examination and grading of lens opacity
Ultrasound examination of the eye to determine distances between cornea lens including lens thickness and retina
Examination of the retina at the back of the eye
Dynamic light scattering of the lens see below
Lens photography using a camera with a bright flash
For the DLS procedure the patient sits in front of the DLS device with his or her chin placed on a chin rest and fixes on a yellow target in the center of the camera lens When the eye is properly aligned DLS measurements are taken on the lens
Healthy normal volunteers and patients with age-related cataract between 18 and 80 years of age may be eligible for this study Participants undergo the following tests and procedures
Medical history
Eye examination including the following
Measurement of visual acuity vision chart
Measurement of eye pressure
Dilation of the pupils for slit lamp microscope examination and grading of lens opacity
Ultrasound examination of the eye to determine distances between cornea lens including lens thickness and retina
Examination of the retina at the back of the eye
Dynamic light scattering of the lens see below
Lens photography using a camera with a bright flash
For the DLS procedure the patient sits in front of the DLS device with his or her chin placed on a chin rest and fixes on a yellow target in the center of the camera lens When the eye is properly aligned DLS measurements are taken on the lens
Detailed Description:
A new non invasive in vivo technique to study the molecular changes in the human lens called Dynamic Light Scattering Device DLS has recently been developed Preliminary studies have shown its potential to detect the earliest changes in cataract at the stage where anti-cataract treatment would be most effective in reversing delaying or preventing cataracts A new miniaturized version of this device has been developed by NASA using lower energy lasers and under a NASA-NEI Inter Agency Agreement has been successfully developed into a clinical device at the NEI We recently conducted pilot studies to evaluate the usefulness and reproducibility of this instrument for quantitating human lens changes and found good reproducibility We also derived a useful parameter to use with this new technique the log mean particle size derived from particle size distribution data Preliminary studies have also shown that the NASA-NEI DLS device can be used to detect and monitor molecular changes in early cataract formation as well as in normal aging We therefore propose to conduct a larger cross sectional clinical study to detect and monitor molecular changes in the lens in early cataract formation and in normal aging
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 |
|---|---|---|---|
| 04-EI-0166 | None | None | None |