NCT00000148

Brief Summary

To assess the long-range outcomes of sequences of interventions involving trabeculectomy and argon laser trabeculoplasty in eyes that have failed initial medical treatment for glaucoma.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

13 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

April 1, 1988

Completed
11.5 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 5, 2006

Status Verified

October 1, 2003

First QC Date

September 23, 1999

Last Update Submit

June 2, 2006

Conditions

Glaucoma

Interventions

Argon Laser TrabeculoplastyPROCEDURE
TrabeculectomyPROCEDURE

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women between the ages of 35 and 80 with open-angle glaucoma that was not successfully controlled by medication were eligible for enrollment.

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

Sponsors & Collaborators

Study Sites (13)

Yale University School of Medicine, Yale Eye Center

New Haven, Connecticut, United States

Location

Georgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.

Washington D.C., District of Columbia, United States

Location

Emory University, Emory Eye Center

Atlanta, Georgia, United States

Location

Piedmont Hospital, Eye Consultants of Atlanta

Atlanta, Georgia, United States

Location

Humana Health Plan Sykes Center

Chicago, Illinois, United States

Location

University of Illinois, Eye and Ear Infirmary

Chicago, Illinois, United States

Location

Washington Hospital Center, Washington Eye Physicians and Surgeons

Chevy Chase, Maryland, United States

Location

University of Michigan, W.K. Kellogg Eye Center

Ann Arbor, Michigan, United States

Location

Sinai Hospital, Detroit, Franklin Eye Consultants

Southfield, Michigan, United States

Location

Ohio State University, Department of Ophthalmology, Ophthalmic Surgeons and Consultants

Columbus, Ohio, United States

Location

Wills Eye Hospital, Glaucoma Service

Philadelphia, Pennsylvania, United States

Location

University of Virginia Medical Center, Department of Ophthalmology

Charlottesville, Virginia, United States

Location

Medical College of Virginia, Department of Ophthalmology

Richmond, Virginia, United States

Location

Related Publications (7)

  • The Advanced Glaucoma Intervention Study (AGIS) Manual of Operations. Springfield, Virginia., National Technical Information Service, 1993;No. PB93-220192

    BACKGROUND

  • Ederer F, Gaasterland DE, Sullivan EK; AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients. Control Clin Trials. 1994 Aug;15(4):299-325. doi: 10.1016/0197-2456(94)90046-9.

    PMID: 7956270BACKGROUND

  • Advanced Glaucoma Intervention Study. 2. Visual field test scoring and reliability. Ophthalmology. 1994 Aug;101(8):1445-55.

    PMID: 7741836BACKGROUND

  • The Advanced Glaucoma Intervention Study (AGIS) Data Management Handbook. Springfield, Virginia., National Technical Information Service, Document, 1996;No. PB96-137120

    BACKGROUND

  • The Advanced Glaucoma Intervention Study (AGIS): 3. Baseline characteristics of black and white patients. Ophthalmology. 1998 Jul;105(7):1137-45. doi: 10.1016/s0161-6420(98)97012-9.

    PMID: 9663214BACKGROUND

  • The Advanced Glaucoma Intervention Study (AGIS): 4. Comparison of treatment outcomes within race. Seven-year results. Ophthalmology. 1998 Jul;105(7):1146-64. doi: 10.1016/s0161-6420(98)97013-0.

    PMID: 9663215BACKGROUND

  • Caprioli J, Mock D, Bitrian E, Afifi AA, Yu F, Nouri-Mahdavi K, Coleman AL. A method to measure and predict rates of regional visual field decay in glaucoma. Invest Ophthalmol Vis Sci. 2011 Jul 1;52(7):4765-73. doi: 10.1167/iovs.10-6414.

    PMID: 21467178DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

April 1, 1988

Last Updated

June 5, 2006

Record last verified: 2003-10

Locations

US(13)