Lichter P R, Musch D C, Gillespie B W, Guire K E, Janz N K, Wren P A, Mills R P
Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, The University of Michigan, Ann Arbor, Michigan 48105, USA.
Ophthalmology. 2001 Nov;108(11):1943-53. doi: 10.1016/s0161-6420(01)00873-9.
To report interim outcome data, using all available follow-up through 5 years after treatment initiation, in the Collaborative Initial Glaucoma Treatment Study (CIGTS).
Randomized clinical trial.
Six hundred seven newly diagnosed glaucoma patients.
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.
VF loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity (VA), IOP, and cataract were also studied.
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.
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.
在协作性青光眼初始治疗研究（CIGTS）中，报告自治疗开始后长达5年的所有可用随访的中期结果数据。
随机临床试验。
607例新诊断的青光眼患者。
在一项随机临床试验中，607例新诊断的开角型青光眼患者最初接受药物治疗或小梁切除术（使用或不使用5-氟尿嘧啶）。治疗开始及早期随访后，每隔6个月对患者进行临床评估。此外，以与临床就诊相似的频率进行生活质量电话访谈。CIGTS两组患者均积极接受治疗，以使眼压（IOP）降至每只眼睛特定的预定目标压力或更低水平。通过特定时间比较和重复测量模型分析视野（VF）评分。
VF丧失是CIGTS的主要结局变量。还研究了视力（VA）、IOP和白内障等次要结局。
基于4年的完整随访以及部分5年的随访，初始治疗对VF丧失无显著差异。在整个随访期间，与药物治疗患者相比，手术治疗患者发生严重VA丧失的风险更高。然而，治疗4年后，两组的平均视力大致相等。在随访过程中，药物治疗组的IOP平均为17至18 mmHg，而手术治疗组的IOP平均为14至15 mmHg。手术治疗组需要摘除白内障的发生率更高。
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结局大致相同。手术治疗组的VA丧失更大，但随着随访的持续，两组之间的差异似乎在缩小。当采用旨在从基线大幅降低IOP的积极治疗时，总体上VF丧失可降至最低。由于对一种慢性病进行4至5年的随访不足以得出治疗结论，因此CIGTS的这些中期结果不支持改变目前开角型青光眼的治疗方法。
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