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
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000144
First Posted
September 23, 1999
Last Updated
June 2, 2006
Sponsor
National Eye Institute (NEI)
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
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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
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Glaucoma Laser Trial (GLT) Glaucoma Laser Trial Followup Study (GLTFS)
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