NCT00081991

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2004

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 28, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2005

First QC Date

April 28, 2004

Last Update Submit

March 3, 2008

Conditions

Keywords

CataractBlindnessClinicalHuman AgingDynamic Light Scattering (DLS)Aging-Related Lens ChangesEarly CataractLensAREDS GradingIn VivoHealthy Volunteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 years will be admitted to this study. There will be no racial or gender bias in the recruitment.
  • patients with AREDS nuclear cataract grades 2 or less will be enrolled in the study. 40 patients with AREDS nuclear cataract grade 3 and 4 will also be enrolled.
  • For those patients enrolled in the study, both eyes will be evaluated for this protocol. However, the participant has the right to choose to undergo measurements only in one eye. In that case, the eye to be examined will be determined by the partipantt's birth month. If the patient's birth month is an even number, the right eye will be examined; if the patient's birth month is odd, the left eye will be examined.

You may not qualify if:

  • Subjects who have tear film disorders, corneal opacities or disorders, uveitis, glaucoma or who have difficulty fixating, will be excluded.
  • Subjects 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, will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Benedek GB, Chylack LT Jr, Libondi T, Magnante P, Pennett M. Quantitative detection of the molecular changes associated with early cataractogenesis in the living human lens using quasielastic light scattering. Curr Eye Res. 1987 Dec;6(12):1421-32. doi: 10.3109/02713688709044506.

    PMID: 3427992BACKGROUND
  • Datiles M, Podgor M, Edwards P. Reproducibility of the Early Cataract Detector (Kowa ECD 2000). Ophthalmic Surg. 1988 Sep;19(9):664-6.

    PMID: 3186178BACKGROUND
  • Bursell SE, Baker RS, Weiss JN, Haughton JF, Rand LI. Clinical photon correlation spectroscopy evaluation of human diabetic lenses. Exp Eye Res. 1989 Aug;49(2):241-58. doi: 10.1016/0014-4835(89)90094-8.

    PMID: 2767171BACKGROUND

MeSH Terms

Conditions

CataractBlindness

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

April 28, 2004

First Posted

April 28, 2004

Study Start

April 1, 2004

Study Completion

April 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-04

Locations