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原发性小梁切除术与引流管植入术研究的视野结果。

Visual Field Outcomes in the Primary Tube Versus Trabeculectomy Study.

机构信息

Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.

Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.

出版信息

Ophthalmology. 2024 Oct;131(10):1157-1163. doi: 10.1016/j.ophtha.2024.03.026. Epub 2024 Apr 4.

Abstract

PURPOSE

To describe visual field outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study.

DESIGN

Cohort analysis.

PARTICIPANTS

A total of 155 eyes (155 subjects) randomly assigned to treatment with tube shunt surgery (n = 84) or trabeculectomy with mitomycin C (n = 71).

METHODS

The PTVT Study was a multicenter randomized clinical trial comparing the safety and efficacy of trabeculectomy and tube shunt surgery in eyes without previous intraocular surgery. Subjects underwent standard automated perimetry (SAP) at baseline and annually for 5 years. Standard automated perimetry tests were deemed reliable if the false-positive rate was ≤ 15%. Tests were excluded if visual acuity was ≤ 20/400 or loss of ≥ 2 Snellen lines from baseline because of a nonglaucomatous etiology. Linear mixed-effects models were used to compare rates of change in SAP mean deviation (MD) between the 2 groups. Intraocular pressure (IOP) control was assessed by percentage of visits with IOP < 18 mmHg and mean IOP.

MAIN OUTCOME MEASURES

Rate of change in SAP MD during follow-up.

RESULTS

A total of 730 SAP tests were evaluated (average of 4.7 tests per eye). The average SAP MD at baseline was -12.8 ± 8.3 decibels (dB) in the tube group and -12.0 ± 8.4 dB in the trabeculectomy group (P = 0.57). The mean rate of change in SAP MD was -0.32 ± 0.39 dB/year in the trabeculectomy group and -0.47 ± 0.43 dB/year in the tube group (P = 0.23). Eyes with mean IOP 14 to 17.5 mmHg had significantly faster rates of SAP MD loss compared with eyes with mean IOP < 14 mmHg (-0.59 ± 0.13 vs. -0.27 ± 0.08 dB/year; P = 0.012), and eyes with only 50% to 75% of visits with IOP < 18 mmHg had faster rates than those with 100% of visits with IOP < 18 mmHg (-0.90 ± 0.16 vs. -0.29 ± 0.08 dB/year; P < 0.001). Multivariable analysis identified older age and worse IOP control as risk factors for faster progression in both treatment groups.

CONCLUSIONS

No statistically significant difference in mean rates of visual field change was observed between trabeculectomy and tube shunt surgery in the PTVT Study. Worse IOP control was significantly associated with faster rates of SAP MD loss during follow-up. Older patients were also at risk for faster progression.

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

摘要

目的

描述原发性引流管与小梁切除术(PTVT)研究中的视野结果。

设计

队列分析。

参与者

共有 155 只眼(155 例患者)随机分配接受引流管手术(n=84)或小梁切除术联合丝裂霉素 C(n=71)治疗。

方法

PTVT 研究是一项多中心随机临床试验,比较了原发性引流管与小梁切除术治疗无既往眼内手术史的眼的安全性和疗效。患者在基线和第 1、2、3、4、5 年接受标准自动视野计(SAP)检查。如果假阳性率≤15%,则认为 SAP 测试可靠。如果视力≤20/400 或因非青光眼病因导致基线时视力丧失≥2 行 Snellen,则排除测试。使用线性混合效应模型比较两组 SAP 平均偏差(MD)变化率。通过眼压(IOP)<18mmHg 的就诊百分比和平均 IOP 评估眼压控制情况。

主要观察指标

随访期间 SAP MD 的变化率。

结果

共评估了 730 次 SAP 测试(平均每只眼 4.7 次)。引流组 SAP MD 的基线平均水平为-12.8±8.3dB,小梁切除术组为-12.0±8.4dB(P=0.57)。小梁切除术组 SAP MD 的平均变化率为-0.32±0.39dB/年,引流组为-0.47±0.43dB/年(P=0.23)。IOP 为 14 至 17.5mmHg 的眼与 IOP<14mmHg 的眼相比,SAP MD 丧失速度更快(-0.59±0.13 vs.-0.27±0.08dB/年;P=0.012),IOP<18mmHg 的就诊百分比为 50%至 75%的眼与 IOP<18mmHg 的就诊百分比为 100%的眼相比,SAP MD 丧失速度更快(-0.90±0.16 vs.-0.29±0.08dB/年;P<0.001)。多变量分析确定年龄较大和眼压控制较差是两组治疗中视野进展更快的危险因素。

结论

在 PTVT 研究中,小梁切除术与引流管手术之间的平均视野变化率无统计学差异。眼压控制较差与随访期间 SAP MD 丧失速度加快显著相关。老年患者也有更快进展的风险。

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