Mansouri Kaweh, Medeiros Felipe A, Tafreshi Ali, Weinreb Robert N
Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/archophthalmol.2012.2280.
OBJECTIVE To examine the safety, tolerability, and reproducibility of intraocular pressure (IOP) patterns during repeated continuous 24-hour IOP monitoring with a contact lens sensor. METHODS Forty patients suspected of having glaucoma (n = 21) or with established glaucoma (n = 19) were studied. Patients participated in two 24-hour IOP monitoring sessions (S1 and S2) at a 1-week interval (SENSIMED Triggerfish CLS; Sensimed AG). Patients pursued daily activities, and sleep behavior was not controlled. Incidence of adverse events and tolerability (visual analog scale score) were assessed. Reproducibility of signal patterns was assessed using Pearson correlations. RESULTS The mean (SD) age of the patients was 55.5 (15.7) years, and 60% were male. Main adverse events were blurred vision (82%), conjunctival hyperemia (80%), and superficial punctate keratitis (15%). The mean (SD) visual analog scale score was 27.2 (18.5) mm in S1 and 23.8 (18.7) mm in S2 (P = .22). Overall correlation between the 2 sessions was 0.59 (0.51 for no glaucoma medication and 0.63 for glaucoma medication) (P = .12). Mean (SD) positive linear slopes of the sensor signal from wake to 2 hours into sleep were detected in both sessions for the no glaucoma medication group (S1: 0.40 [0.34], P < .001; S2: 0.33 [0.30], P < .01) but not for the glaucoma medication group (S1: 0.24 [0.60], P = .06; S2: 0.40 [0.40], P < .001). CONCLUSIONS Repeated use of the contact lens sensor demonstrated good safety and tolerability. The recorded IOP patterns showed fair to good reproducibility, suggesting that data from continuous 24-hour IOP monitoring may be useful in the management of patients with glaucoma. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01319617.
目的 采用隐形眼镜传感器进行连续24小时眼压（IOP）重复监测，以检验IOP模式的安全性、耐受性和可重复性。方法 对40例疑似青光眼患者（n = 21）或确诊青光眼患者（n = 19）进行研究。患者每隔1周参加两次24小时IOP监测（S1和S2）（SENSIMED Triggerfish CLS；Sensimed AG公司）。患者进行日常活动，睡眠行为未受控制。评估不良事件发生率和耐受性（视觉模拟量表评分）。使用Pearson相关性评估信号模式的可重复性。结果 患者的平均（标准差）年龄为55.5（15.7）岁，60%为男性。主要不良事件为视力模糊（82%）、结膜充血（80%）和浅层点状角膜炎（15%）。S1时视觉模拟量表评分的平均（标准差）为27.2（18.5）mm，S2时为23.8（18.7）mm（P = 0.22）。两次监测之间的总体相关性为0.59（未使用青光眼药物者为0.51，使用青光眼药物者为0.63）（P = 0.12）。未使用青光眼药物组在两次监测中均检测到从清醒到入睡2小时期间传感器信号的平均（标准差）正线性斜率（S1：0.40 [0.34]，P < 0.001；S2：0.33 [0.30]，P < 0.01），而使用青光眼药物组未检测到（S1：0.24 [0.60]，P = 0.06；S2：0.40 [0.40]，P < 0.001）。结论 重复使用隐形眼镜传感器显示出良好的安全性和耐受性。记录的IOP模式显示出尚可至良好的可重复性，表明连续24小时IOP监测的数据可能有助于青光眼患者的管理。试验注册 clinicaltrials.gov标识符：NCT01319617。
