NCT00067483

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2003

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2003

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2003

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2007

Completed
Last Updated

July 2, 2017

Status Verified

December 10, 2007

First QC Date

August 20, 2003

Last Update Submit

June 30, 2017

Conditions

Keywords

CataractPre-SenileDynamic Light Scattering (DLS)Light ScatteringLensCataracts

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

NASA-John Glenn Research Center

Cleveland, Ohio, United States

Location

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

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

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

Locations