NCT00007215

Brief Summary

This study will use a newly developed instrument called dynamic light scattering device (DLS) to examine age-related changes in the human lens and to study the causes and development of cataracts. 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 stages, when anti-cataract treatment would be most effective in reversing, delaying or preventing cataract formation. Patients 18 years of age and older with cataracts and normal volunteers between the ages of 18 and 70 years may be eligible for this study. Participants will have a standard eye examination, including a vision check, pressure measurement, lens examination using DLS and examination of the retina. Photographs of the lens or retina, or both, may be taken. This study does not involve treatment. No anti-cataract medications will be given.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2000

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2000

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2004

First QC Date

December 15, 2000

Last Update Submit

March 3, 2008

Conditions

Keywords

CataractEarly Lens ChangesProtein AggregationBlindnessVisionDynamic Laser Scattering (DLS)Age-Related ChangesTest Re-test ReproducibilityNormal VolunteersLensHealthy Volunteer

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years or older will be admitted to this study.
  • There will be no gender or sex bias in the recruitment.
  • Fifteen subjects (30 eyes) who are normal volunteers of either sex, 3 for each decade from 18-70, will be recruited.
  • These normal volunteers should have clear lenses with LOCS II clinical score for nuclear opalescence of 0.5 or less.
  • Three patients (18 eyes) for each major type of cataract (nuclear, cortical and PSC), will be recruited also for evaluation with the DLS device.
  • All 3 types of cataracts will be graded using the LOCS II system and will have a clinical score of at least one.

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 (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
  • 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
  • Chylack LT Jr, Leske MC, McCarthy D, Khu P, Kashiwagi T, Sperduto R. Lens opacities classification system II (LOCS II). Arch Ophthalmol. 1989 Jul;107(7):991-7. doi: 10.1001/archopht.1989.01070020053028.

    PMID: 2751471BACKGROUND

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

December 15, 2000

First Posted

December 18, 2000

Study Start

December 1, 2000

Study Completion

February 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-02

Locations