The Collaborative Initial Glaucoma Treatment Study: study design, methods, and baseline characteristics of enrolled patients.
OBJECTIVE
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.


METHODS
Randomized, controlled clinical trial.


METHODS
A total of 607 patients with open-angle glaucoma were enrolled.


METHODS
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Musch
D C
DC
Department of Ophthalmology, The University of Michigan, Ann Arbor 48105, USA.
Lichter
P R
PR
Guire
K E
KE
Standardi
C L
CL
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000379:methods*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012107:Research Design; D014130:Trabeculectomy; D014792:Visual Acuity; D014794:Visual Fields
D000319:Adrenergic beta-Antagonists