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Ophthalmology. 1999 Apr;106(4):653-62.

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

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1
Department of Ophthalmology, The University of Michigan, Ann Arbor 48105, USA.

Abstract

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.

DESIGN:

Randomized, controlled clinical trial.

PARTICIPANTS:

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

INTERVENTION:

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.

MAIN OUTCOME MEASURES:

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.

PMID:
10201583
DOI:
10.1016/s0161-6420(99)90147-1
[Indexed for MEDLINE]

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