Ophthalmology · 1999
The Collaborative Initial Glaucoma Treatment Study: study design, methods, and baseline characteristics of enrolled patients.
Клиническое исследованиеСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка службы здравоохранения СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Musch D C, Lichter P R, Guire K E, Standardi C L
Аннотация
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.
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.