Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, Michigan 48105, USA.
Ophthalmology. 2011 Sep;118(9):1766-73. doi: 10.1016/j.ophtha.2011.01.047. Epub 2011 May 20.
To evaluate the impact of measures of intraocular pressure (IOP) control on progression of visual field (VF) loss during long-term treatment for open-angle glaucoma (OAG).
Longitudinal, randomized clinical trial.
We included 607 participants with newly diagnosed OAG.
Study participants were randomly assigned to initial treatment with medications or trabeculectomy, and underwent examination at 6-month intervals. Standardized testing included Goldmann applanation tonometry and Humphrey 24-2 full threshold VFs. Summary measures of IOP control during follow-up included the maximum, mean, standard deviation (SD), range, proportion less than 16, 18, 20, or 22 mmHg, and whether all IOP values were less than each of these 4 cutpoints. Predictive models for VF outcomes were based on the mean deviation (MD) from VF testing, and were adjusted for age, gender, race, baseline VF loss, treatment, and time. Each summary IOP measure was included as a cumulative, time-dependent variable, and its association with subsequent VF loss was assessed from 3 to 9 years postrandomization. Both linear mixed models, to detect shifts in MD levels, and logistic models, to detect elevated odds of substantial worsening (≥3 dB), were used.
We measured the MD from Humphrey 24-2 full threshold VF tests.
The effect of the summary IOP measures differed between the medicine and surgery groups in models that addressed the continuous MD outcome. After adjustment for baseline risk factors, in the medicine group larger values of 3 IOP control measures-maximum IOP (P = 0.0003), SD of IOP (P = 0.0056), and range of IOP (P<0.0001)-were significantly associated with lower (worse) MD over the 3- to 9-year period. No IOP summary measure was significantly associated with MD over time in the surgery group. The same 3 IOP summary measures were also significantly associated with substantial worsening of MD; however, the effects were similar in both treatment groups. In models predicting inadequate IOP control, consistently significant predictors of higher maximum, SD, and range of IOP included black race, higher baseline IOP, and clinical center.
These results support considering more aggressive treatment when undue elevation or variation in IOP measures is observed.
评估长期治疗开角型青光眼（OAG）过程中眼压（IOP）控制措施对视野（VF）丧失进展的影响。
纵向、随机临床试验。
我们纳入了 607 名新诊断为 OAG 的患者。
研究参与者被随机分配接受药物或小梁切除术的初始治疗，并每 6 个月进行一次检查。标准测试包括 Goldmann 压平眼压计和 Humphrey 24-2 全阈值 VF。随访期间 IOP 控制的综合测量指标包括最大、平均、标准差（SD）、范围、比例小于 16、18、20 或 22mmHg，以及所有 IOP 值是否均小于这 4 个切点中的每一个。VF 结果的预测模型基于 VF 测试的平均偏差（MD），并根据年龄、性别、种族、基线 VF 损失、治疗和时间进行了调整。每个综合 IOP 测量值均作为累积的、随时间变化的变量，从随机分组后 3 至 9 年评估其与随后的 VF 损失的相关性。线性混合模型用于检测 MD 水平的变化，逻辑模型用于检测显著恶化（≥3dB）的可能性增加。
我们测量了 Humphrey 24-2 全阈值 VF 测试的 MD。
在针对连续 MD 结果的模型中，综合 IOP 测量值在药物组和手术组之间的效果不同。在调整基线风险因素后，在药物组中，3 个 IOP 控制措施的较大值——最大 IOP（P=0.0003）、IOP 的 SD（P=0.0056）和 IOP 的范围（P<0.0001）——与 3 至 9 年期间 MD 的下降（恶化）显著相关。在手术组中，没有任何 IOP 综合测量值与时间相关的 MD 显著相关。这 3 个 IOP 综合测量值也与 MD 的显著恶化显著相关；然而，在两组治疗中，效果相似。在预测 IOP 控制不足的模型中，较高的最大、SD 和 IOP 范围的一致显著预测因子包括黑人种族、较高的基线 IOP 和临床中心。
这些结果支持在观察到 IOP 测量值升高或波动时考虑更积极的治疗。
