The collaborative initial glaucoma treatment study: Study design, methods, and baseline characteristics of enrolled patients

• Published in: Ophthalmology (Rochester, Minn.) Vol. 106; no. 4; pp. 653 - 662
• Main Authors: Musch, David C, Lichter, Paul R, Guire, Kenneth E, Standardi, Carol L
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.04.1999; Elsevier
• Subjects: Adrenergic beta-Antagonists - therapeutic use; Adult; Aged; Biological and medical sciences; Clinical Trials as Topic - methods; Drug Therapy, Combination; Female; Follow-Up Studies; Glaucoma and intraocular pressure; Glaucoma, Open-Angle - diagnosis; Glaucoma, Open-Angle - physiopathology; Glaucoma, Open-Angle - therapy; Humans; Intraocular Pressure; Male; Medical sciences; Middle Aged; Ophthalmology; Quality of Life; Research Design; Trabeculectomy; Visual Acuity; Visual Fields; Antiglaucomatous agent; Human; Eye disease; Chemotherapy; Filtration; Treatment; Open angle glaucoma; Surgery; Controlled therapeutic trial
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/S0161-6420(99)90147-1

The Collaborative Initial Glaucoma Treatment Study (CIGTS) is a randomized, controlled clinical trial designed to determine whether patients with newly diagnosed open-angle glaucoma (primary, pigmentary, or pseudoexfoliative) are better treated by initial treatment with medications or by immediate filtration surgery. Randomized, controlled clinical trial. A total of 607 patients with open-angle glaucoma were enrolled. Patients randomized to initial medications (n=307) received a stepped regimen of medications to lower intraocular pressure. Those randomized to initial surgery (n=300) underwent trabeculectomy to lower intraocular pressure. Progression in visual field loss constitutes the study’s primary outcome variable. Secondary outcomes include health-related quality of life, visual acuity, and intraocular pressure. Randomized assignment resulted in a balanced distribution between treatment groups for most demographic and clinical measures assessed at enrollment. More males than females were enrolled (55% were males), and a substantial percentage (38.1%) of enrollees were blacks. Most enrollees (90.6%) were diagnosed with primary open-angle glaucoma; the remainder had either pseudoexfoliative (4.8%) or pigmentary (4.6%) forms of open-angle glaucoma. Follow-up of this well-characterized group of patients should provide well-rounded guidance, based on both traditional ophthalmic measures and patients’ perspectives on their health-related quality of life, on how best to initially treat open-angle glaucoma.