Pilot Study: Dynamic Light Scattering Device for Studying Early Changes in Cataract
Pilot Study on the Use of the NASA-NEI Dynamic Light Scattering (DLS) Device in Detecting Lens Changes in the Other Eye of Patients With Pre-Senile Cataracts
2 other identifiers
observational
15
1 country
2
Brief Summary
This study will use a new dynamic light scattering device (DLS), developed jointly by NASA and the NEI, to study pre-senile cataracts (cataracts that develop in patients 55 years old or less). Cataract is a clouding of the lens that interferes with the passage of light to the retinal, impairing visual acuity. DLS uses a low intensity laser light (similar to that used in supermarket checkouts) to measures 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. Patients 55 years of age or younger with cataract may be eligible for this study. Candidates will be screened with the following tests and procedures:
- Medical history and physical examination.
- Eye examination, including measurement of visual acuity (vision chart) and eye pressure; examination of pupils and eye movements; dilation of the pupils for examination of the lens and the back of the eye (retina).
- Cataract photography using a camera with a bright flash to assess the status of the cataract and evaluate future changes.
- Blood drawing if necessary for clinical care. Participants will have a standard eye examination, as described above, plus DLS testing. For this procedure, the patient sits in front of the DLS device, with the chin placed on a chin rest. He or she fixes on a yellow-green target in the center of the camera lens. When the eye is properly aligned, the measurement is taken and the reddish light on the side of the camera lens turns on for 5 seconds. Measurements are taken on three layers of the lens. The procedure takes less than 30 minutes. Participants will be followed at the NIH clinic once a month for up to 1 year to follow progression of the cataract. The visits will include a repeat of some of the exams listed above.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2003
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2003
CompletedFirst Submitted
Initial submission to the registry
August 20, 2003
CompletedFirst Posted
Study publicly available on registry
August 21, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2007
CompletedJuly 2, 2017
December 10, 2007
August 20, 2003
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Patients 55 years of age or younger with cataracts (pre-senile cataracts) will be admitted to this study.
- Ten subjects who have cataracts and who are 55 years of age or younger, of either sex, will be recruited. DLS data will be obtained on the eye with no or little cataract every month for a year or until cataract surgery is required. AREDS grading will be utilized but will not be used as a protocol end point.
You may not qualify if:
- Patients who have uveitis, glaucoma and who are thought to be at risk for an adverse reaction to pupil dilation, or have a history of allergic reaction to one of the dilating agents that will be used.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
NASA-John Glenn Research Center
Cleveland, Ohio, United States
Related Publications (1)
Ansari RR, Datiles MB 3rd. Use of dynamic light scattering and Scheimpflug imaging for the early detection of cataracts. Diabetes Technol Ther. 1999 Summer;1(2):159-68. doi: 10.1089/152091599317378.
PMID: 11475288BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 20, 2003
First Posted
August 21, 2003
Study Start
August 15, 2003
Study Completion
December 10, 2007
Last Updated
July 2, 2017
Record last verified: 2007-12-10