NCT00078299

Brief Summary

This study will evaluate a system developed to grade the severity of age-related cataract, a common cause of vision loss in older adults. Cataract research requires methods to simply and accurately determine the type and severity of cataracts in order to develop new, possibly non-surgical, treatments. Patients 50 years of age and older with one of the three major age-related cataract types (nuclear, cortical, and posterior subcapsular) may be eligible for this study. Participants will be recruited from among patients enrolled in other National Eye Institute protocols. Participants will have their eyes examined independently by two ophthalmologists with a biomicroscope, a magnifying device routinely used during eye examinations. The doctors will use the new grading system to record if a cataract is present, and if so, how severe it is. The examination includes measurement of visual acuity (vision chart test) and examination of the lens, retina, pupils and eye movements. Photographs of the eye will be taken using a special camera that flashes a bright light in the eye.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2004

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

February 1, 2004

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2004

Completed
1.1 years 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

February 20, 2004

Last Update Submit

March 3, 2008

Conditions

Keywords

CorticalNuclear SclerosisPosterior SubcapsularPhotographic MethodsReproducibility (intra and interobserver)CataractAgreementGrading System

Eligibility Criteria

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

You may qualify if:

  • Patient must understand and sign the informed consent.
  • Patient must be at least 18 years of age.
  • Pupillary dilation to at least 6 mm must be possible.
  • Patients must have at least one natural lens present.

You may not qualify if:

  • Patients below the age of 18 will be excluded from participation in this study of age-related cataract.
  • \. Any condition such as corneal opacification that precludes adequate slit lamp examination and photography of the lens.

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)

  • Steinberg EP, Javitt JC, Sharkey PD, Zuckerman A, Legro MW, Anderson GF, Bass EB, O'Day D. The content and cost of cataract surgery. Arch Ophthalmol. 1993 Aug;111(8):1041-9. doi: 10.1001/archopht.1993.01090080037016.

    PMID: 8352686BACKGROUND
  • Age-Related Eye Disease Study Research Group. The age-related eye disease study (AREDS) system for classifying cataracts from photographs: AREDS report no. 4. Am J Ophthalmol. 2001 Feb;131(2):167-75. doi: 10.1016/s0002-9394(00)00732-7.

    PMID: 11228291BACKGROUND
  • 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

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

February 20, 2004

First Posted

February 23, 2004

Study Start

February 1, 2004

Study Completion

April 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-04

Locations