- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000144
Glaucoma Laser Trial (GLT) Glaucoma Laser Trial Followup Study (GLTFS)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- The Glaucoma Laser Trial (GLT): 5. Subgroup differences at enrollment. Glaucoma Laser Trial Research Group. Ophthalmic Surg. 1993 Apr;24(4):232-40.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEI-43
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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