Collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery

Collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery
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DOI:
10.1016/s0161-6420(01)00873-9
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发表时间:
2001-11-01
期刊:
影响因子:
13.7
通讯作者:
Mils, RP
Mils, RP
中科院分区:
医学1区
文献类型:
--
作者:
Lichter, PR;Musch, DC;Mils, RP

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目的:在合作初始青光眼治疗研究 (CIGTS) 中,利用治疗开始后 5 年的所有可用随访数据来报告中期结果数据。设计:随机临床试验。参与者。 607 名新诊断的青光眼患者。方法:在一项随机临床试验中,607 名新诊断的开角型青光眼患者最初接受药物或小梁切除术(联合或不联合 5-氟尿嘧啶)治疗。治疗开始和早期随访后,每 6 个月对患者进行一次临床评估。此外,生活质量电话访谈的频率与临床访问的频率相似。 CIGTS 两组患者均接受积极治疗,努力将眼内压 (IOP) 降低至等于或低于每只眼睛特定的预定目标压力的水平。通过特定时间比较和重复测量模型对视野 (VF) 评分进行分析。 主要结果测量:VF 损失是 CIGTS 的主要结果变量。还研究了视力 (VA)、IOP 和白内障等次要结果。结果:在完成 4 年随访和部分完成 5 年随访的基础上,初始治疗的 VF 丧失没有显着差异。在整个随访期间,与内科患者相比,手术患者的视力大幅下降的风险更大。然而,到治疗后 4 年,两组的平均视力大致相等。在随访过程中,药物组的平均眼压为17至18毫米汞柱,而手术组的平均眼压为14至15毫米汞柱。手术治疗组中需要摘除白内障的比例更高。结论:经过长达 5 年的随访,初始药物治疗或初始手术治疗导致的 VF 结果大致相同。手术组的视力损失更大,但随着随访的继续,各组之间的差异似乎正在趋同。当采用旨在从基线大幅降低眼压的积极治疗时,一般可以看出室颤的损失很小。由于慢性疾病 4 至 5 年的随访不足以得出治疗结论,因此这些中期 CIGTS 结果不支持改变当前开角型青光眼的治疗方法。眼科 2001;108:1943-1953 (C) 2001 年,美国眼科学会。
Purpose: To report interim outcome data, using all available follow-up through 5 years after treatment initiation, in the Collaborative Initial Glaucoma Treatment Study (CIGTS).Design: Randomized clinical trial.Participants. Six hundred seven newly diagnosed glaucoma patients.Methods: In a randomized clinical trial, 607 patients with newly diagnosed open-angle glaucoma were initially treated with either medication or trabeculectomy (with or without 5-fluorouracil). After treatment onset and early follow-up, patients were evaluated clinically at 6-month intervals. In addition, quality of life telephone interviews were conducted at similar frequency to the clinical visits. Patients in both arms of CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at or below a predetermined target pressure specific for each individual eye. Visual field (VF) scores were analyzed by time-specific comparisons and by repeated measures models.Main Outcome Measures: VF loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity (VA), IOP, and cataract were also studied.Results: On the basis of completed follow-up through 4 years and partially completed through 5 years, VF loss did not differ significantly by initial treatment. Over the entire period of follow-up, surgical patients had a greater risk of substantial VA loss compared with medical patients. However, by 4 years after treatment, the average VA in the two groups was about equal. Over the course of follow-up, IOP in the medicine group has averaged 17 to 18 mmHg, whereas that in the surgery group averaged 14 to 15 mmHg. The rate of cataract requiring removal was greater in the surgically treated group.Conclusions: Both initial medical or initial surgical therapy result in about the same VF outcome after up to 5 years of follow-up. VA loss was greater in the surgery group, but the differences between groups seem to be converging as follow-up continues. When aggressive treatment aimed at substantial reduction in IOP from baseline is used, loss of VF can be seen to be minimal in general. Because 4 to 5 years of follow-up in a chronic disease is not adequate to draw treatment conclusions, these interim CIGTS outcomes do not support altering current treatment approaches to open-angle glaucoma. Ophthalmology 2001;108:1943-1953 (C) 2001 by the American Academy of Ophthalmology.