search
Back to results

Glaucoma Laser Trial (GLT) Glaucoma Laser Trial Followup Study (GLTFS)

Primary Purpose

Open-Angle Glaucoma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Argon Laser Treatment
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

At the time of recruitment, patients had to be at least 35 years old with an intraocular pressure of at least 22 mm Hg or greater in each eye and evidence of optic nerve damage in at least one eye.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 1999
    Last Updated
    June 2, 2006
    Sponsor
    National Eye Institute (NEI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00000144
    Brief Title
    Glaucoma Laser Trial (GLT) Glaucoma Laser Trial Followup Study (GLTFS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2003
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1984 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Eye Institute (NEI)

    4. Oversight

    5. Study Description

    Brief Summary
    To compare the safety and long-term efficacy of argon laser treatment of the trabecular meshwork with standard medical treatment for primary open-angle glaucoma.
    Detailed Description
    During the last decade, argon laser trabeculoplasty (ALT) has often been used instead of surgery as the treatment of choice in cases of open-angle glaucoma that could not be controlled by drugs. ALT treatment consists of tiny laser burns evenly spaced around the trabecular meshwork. It sometimes has been found to be effective in controlling glaucoma, although many eyes still require some medical treatment. The Glaucoma Laser Trial (GLT), a randomized, controlled clinical trial, was conducted to determine whether ALT is effective in patients with newly diagnosed, primary, open-angle glaucoma. Each of the 271 patients in the trial received argon laser treatment in one eye and standard topical medication in the other eye. The eye to be started on medicine and the eye that would get the laser treatment were randomly selected. The Glaucoma Laser Trial Followup Study was a followup study of 203 of the 271 patients who enrolled in the Glaucoma Laser Trial. By the close of the Glaucoma Laser Trial Followup Study, median duration of followup since diagnosis of primary, open-angle glaucoma was 7 years (maximum, 9 years). The argon laser treatment was done in two sessions 1 month apart, with one-half of the trabecular meshwork treated with 45 to 55 laser burns in each session. Patients were seen for a followup visit 3 months after the first laser treatment and every 3 months thereafter for a period of at least 2 years. At each visit, examination of the eyes included a check of intraocular pressure and visual acuity. Visual field examinations were performed 3, 6, and 12 months after randomization and annually thereafter. Disc stereo photographs were taken 6 and 12 months after randomization and annually thereafter. The results of these examinations determined whether treatment should be changed. If the pressure in either eye had not been reduced to the desired level, the physician changed the medication in the eye treated with drops or started the use of drops in the laser-treated eye according to a standardized procedure being used in the trial. If intraocular pressure was still not successfully reduced, surgery or further laser treatment may have been required.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open-Angle Glaucoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Argon Laser Treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    At the time of recruitment, patients had to be at least 35 years old with an intraocular pressure of at least 22 mm Hg or greater in each eye and evidence of optic nerve damage in at least one eye.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    2255512
    Citation
    The Glaucoma Laser Trial (GLT). 2. Results of argon laser trabeculoplasty versus topical medicines. The Glaucoma Laser Trial Research Group. Ophthalmology. 1990 Nov;97(11):1403-13.
    Results Reference
    background
    PubMed Identifier
    1657527
    Citation
    The Glaucoma Laser Trial (GLT): 3. Design and methods. Glaucoma Laser Trial Research Group. Control Clin Trials. 1991 Aug;12(4):504-24. doi: 10.1016/0197-2456(91)90010-j.
    Results Reference
    background
    PubMed Identifier
    1896168
    Citation
    The Glaucoma Laser Trial: 4. Contralateral effects of timolol on the intraocular pressure of eyes treated with ALT. GLT Research Group. Ophthalmic Surg. 1991 Jun;22(6):324-9.
    Results Reference
    background
    PubMed Identifier
    8321504
    Citation
    The Glaucoma Laser Trial (GLT): 5. Subgroup differences at enrollment. Glaucoma Laser Trial Research Group. Ophthalmic Surg. 1993 Apr;24(4):232-40.
    Results Reference
    background
    PubMed Identifier
    7611312
    Citation
    The Glaucoma Laser Trial (GLT): 6. Treatment group differences in visual field changes. Glaucoma Laser Trial Research Group. Am J Ophthalmol. 1995 Jul;120(1):10-22. doi: 10.1016/s0002-9394(14)73754-7.
    Results Reference
    background
    PubMed Identifier
    8540545
    Citation
    The Glaucoma Laser Trial (GLT) and glaucoma laser trial follow-up study: 7. Results. Glaucoma Laser Trial Research Group. Am J Ophthalmol. 1995 Dec;120(6):718-31. doi: 10.1016/s0002-9394(14)72725-4.
    Results Reference
    background
    PubMed Identifier
    2667508
    Citation
    The Glaucoma Laser Trial. I. Acute effects of argon laser trabeculoplasty on intraocular pressure. Glaucoma Laser Trial Research Group. Arch Ophthalmol. 1989 Aug;107(8):1135-42.
    Results Reference
    background
    Links:
    URL
    http://www.nei.nih.gov/news/pressreleases/gltpressrelease.asp
    Description
    NEI Press Release-Laser Surgery Is Safe And Effective First Treatment For Glaucoma
    URL
    http://www.nei.nih.gov/news/pressreleases/glt-1pressrelease.asp
    Description
    NEI Press Release-Laser Therapy Show Promise As Alternative to Glaucoma Drugs

    Learn more about this trial

    Glaucoma Laser Trial (GLT) Glaucoma Laser Trial Followup Study (GLTFS)

    We'll reach out to this number within 24 hrs