Dynamic Light Scattering Device (DLS) Study of Age-Related Changes in the Lens and Cataracts

March 3, 2008 updated by: National Eye Institute (NEI)

A Study of Age-Related Changes in the Human Lens and Cataracts In Vivo Using Dynamic Light Scattering Device (DLS) Combined With Keratoscopy

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Recently, a device has been created to determine molecular interactions that occur in the nucleus of the lens, called Dynamic Light Scattering Device (DLS). Preliminary studies have shown its potential in the detection of the earliest changes occurring in cataract, at the stage where anticataract treatment would theoretically 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 offered for further development and testing at the NEI. We recently conducted a pilot study to evaluate the usefulness and reproducibility of this instrument for quantitating lens changes, and found good reproducibility. We also determined that the most useful parameter to use is mean particle size derived from particle size distribution. We therefore propose to conduct a study on changes on the lens due to aging (age related changes), as well as on the three representative types of cataracts (nuclear, cortical and PSC).

Study Type

Observational

Enrollment

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Eye Institute (NEI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

INCLUSION:

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.

EXCLUSION:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

February 1, 2004

Study Registration Dates

First Submitted

December 15, 2000

First Submitted That Met QC Criteria

December 15, 2000

First Posted (Estimate)

December 18, 2000

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

February 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010051
  • 01-EI-0051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe