The Collaborative Initial Glaucoma Treatment Study - Study design, methods, and baseline characteristics of enrolled patients
The Collaborative Initial Glaucoma Treatment Study - Study design, methods, and baseline characteristics of enrolled patients
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DOI：
10.1016/s0161-6420(99)90147-1
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发表时间：
1999-04-01
期刊：
影响因子：
13.7
通讯作者：
Standardi, CL
中科院分区：
文献类型：
--
作者：
Musch, DC;Lichter, PR;Standardi, CL
目的：青光眼初始治疗合作研究（CIGTS）是一项随机对照临床试验，旨在确定新诊断的开角型青光眼患者是否（原发性、色素性或假性剥脱性）开角型青光眼最好通过药物治疗或立即进行滤过手术治疗。设计：随机对照临床试验。参与者：共607例开角型青光眼患者。干预：随机接受初始药物治疗的患者（n=307）接受了阶梯式药物治疗方案以降低眼内压。随机分配到初始手术组的患者（n=300）接受小梁切除术以降低眼内压。主要结果测量：视野丧失的进展构成了研究的主要结果变量。次要结果包括健康相关的生活质量，视力，和眼内压。结果：随机分配导致治疗组之间的分布均衡，大多数人口统计学和临床措施评估在登记。入学的男性多于女性（55%为男性），入学者中有相当大的比例（38.1%）是黑人。大多数入学者（90.6%）被诊断为原发性开角型青光眼;其余患者有假性剥脱性青光眼，（4.8%）或猪（4.6%）类型的开角型青光眼。根据传统眼科测量和患者对健康相关生活质量的看法，对这一特征明确的患者组的随访应提供全面的指导，如何最好地治疗开角型青光眼。
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.