NCT00001613

Brief Summary

Cataract, in which the lens of the eye is opacified, is the major cause of blindness. This study will examine protein material of the lens called crystallins to try to determine what causes nuclear cataracts, a type of cataract that forms in the central lens nucleus. Men and women age 45 years or older with a cataract may be eligible for this study. Candidates will be screened to determine what type of cataract they have and will undergo a complete eye examination, including a vision test, eye pressure test, and examination of the lens and retina. Patients selected for study will have a complete physical and eye examination, including photography of various parts of the eye, and ultrasound measurements of the eye. They will then have cataract surgery, either with or without intraocular lens implantation, and will have follow-up examinations 1 week, 3 weeks, 5 weeks and 8 weeks after surgery. Tissue from the lenses removed during surgery will be given to NEI scientists for research on the causes of age-related nuclear cataracts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 1997

Longer than P75 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

May 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 2002

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Cataract SurgeryHuman LensCrystallinsPost-TranslationalProtein ModificationNuclear CataractCataract Extraction

Eligibility Criteria

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

You may qualify if:

  • Patients with cataracts will be screened in order to determine eligibility.
  • Patients 45 years and older of either sex with clinically significant cataract will be admitted to this study.
  • Patients requiring cataract surgery should have either age related nuclear cataracts or cortical and/or posterior subcapsular cataract without nuclear cataract (controls).
  • Age related nuclear cataract is defined using LOCS II Clinical Classification as having Nuclear color of 0-2, Nuclear Opalescence of 2-5, Cortical Opacity 0-1, and PSC 0-1.
  • In addition, for controls, patients of either sex with clinically significant cortical or posterior subcapsular cataracts but having no nuclear cataract will also be recruited. These will have a LOCS grade of Nuclear Color 0-2, Nuclear Opalescence 0-1, Cortical 1-5, PSC 1.4.

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)

  • Datiles MB, Schumer DJ, Zigler JS Jr, Russell P, Anderson L, Garland D. Two-dimensional gel electrophoretic analysis of human lens proteins. Curr Eye Res. 1992 Jul;11(7):669-77. doi: 10.3109/02713689209000740.

    PMID: 1521468BACKGROUND
  • Foster A, Johnson GJ. Magnitude and causes of blindness in the developing world. Int Ophthalmol. 1990 May;14(3):135-40. doi: 10.1007/BF00158310. No abstract available.

    PMID: 2188914BACKGROUND
  • Dilley KJ. The proportion of protein from the normal and cataractous human lens which exists as high molecular weight aggregates in vitro. Exp Eye Res. 1975 Jan;20(1):73-8. doi: 10.1016/0014-4835(75)90109-8. No abstract available.

    PMID: 1193192BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

May 1, 1997

Study Completion

May 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-05

Locations