NCT00000155

Brief Summary

To describe the clinical course of keratoconus and to describe the relationships among its visual and physiological manifestations, including high- and low-contrast visual acuity, corneal curvature, slit lamp biomicroscopic findings, corneal scarring, and quality of life. To identify risk factors and protective factors that influence the severity and progression of keratoconus.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

14 active sites

Status
unknown

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

June 1, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 2001

First QC Date

September 23, 1999

Last Update Submit

June 23, 2005

Conditions

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Patients with keratoconus were eligible if they were at least 12 years old; had an irregular cornea as determined by keratometry, retinoscopy, or direct ophthalmoscopy in at least one eye; had Vogt's striae, Fleischer's ring, or corneal scarring characteristic of keratoconus in at least one eye; and planned to stay in the area for at least 3 years. They were ineligible if they had bilateral corneal transplants or bilateral nonkeratoconic eye disease (cataract, intraocular lenses, macular disease, or optic nerve disease other than glaucoma).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (14)

University of California, Berkeley, School of Optometry

Berkeley, California, 94720-2020, United States

Location

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

Jules Stein Eye Institute, University of California at Los Angeles

Los Angeles, California, 90095-7003, United States

Location

Nova Southeastern University, Health Professions Division, College of Optometry

Fort Lauderdale, Florida, 33328, United States

Location

University of Illinois at Chicago, Department of Ophthalmology and Visual Sciences

Chicago, Illinois, 60612, United States

Location

Indiana University, School of Optometry

Bloomington, Indiana, 47405-3680, United States

Location

University of Missouri-St. Louis, School of Optometry

St Louis, Missouri, 63121, United States

Location

SUNY State College of Optometry

New York, New York, 10036-8003, United States

Location

University Hospitals of Cleveland, Department of Ophthalmology

Cleveland, Ohio, 44106, United States

Location

The Ohio State University, College of Optometry

Columbus, Ohio, 43210-1240, United States

Location

Pennsylvania College of Optometry, The Eye Institute

Philadelphia, Pennsylvania, 19141, United States

Location

Northeastern Eye Institute

Scranton, Pennsylvania, 18503, United States

Location

University of Utah, John Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

Gundersen Lutheran

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (4)

  • Barr JT, Gordon MO, Zadnik K, Pellican K, Edrington TB. Photodocumentation of corneal scarring. Collaborative Longitudinal Evaluation of Keratoconus Study Group. J Refract Surg. 1996 May-Jun;12(4):492-500. doi: 10.3928/1081-597X-19960501-13.

    PMID: 8771545BACKGROUND
  • Edrington TB, Barr JT, Zadnik K, Davis LJ, Gundel RE, Libassi DP, McMahon TT, Gordon MO. Standardized rigid contact lens fitting protocol for keratoconus. Optom Vis Sci. 1996 Jun;73(6):369-75. doi: 10.1097/00006324-199606000-00003.

    PMID: 8807647BACKGROUND
  • Gundel RE, Libassi DP, Zadnik K, Barr JT, Davis L, McMahon TT, Edrington TB, Gordon MO. Feasibility of fitting contact lenses with apical clearance in keratoconus. Optom Vis Sci. 1996 Dec;73(12):729-32. doi: 10.1097/00006324-199612000-00002.

    PMID: 9002088BACKGROUND
  • Zadnik K, Barr JT, Gordon MO, Edrington TB. Biomicroscopic signs and disease severity in keratoconus. Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study Group. Cornea. 1996 Mar;15(2):139-46. doi: 10.1097/00003226-199603000-00006.

    PMID: 8925661BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

June 1, 1995

Last Updated

June 24, 2005

Record last verified: 2001-11

Locations