Samuelson Thomas W, Ferguson Tanner J, Radcliffe Nathan M, Lewis Richard, Schweitzer Justin, Swan Russell, Berdahl John P
Minnesota Eye Consultants, Minneapolis, MN, USA.
Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA.
Clin Ophthalmol. 2019 Oct 2;13:1947-1953. doi: 10.2147/OPTH.S217736. eCollection 2019.
To investigate the safety and tolerability of the multi-pressure dial with a continuous 8-hr duration in subjects with open-angle glaucoma.
Prospective, controlled open-label, randomized, single site study.
Twenty eyes of 10 subjects with open-angle glaucoma were fitted with a multi-pressure dial and randomized to negative pressure application of -10 mmHg in one eye for 8 (continuous) hours and ambient atmospheric pressure in the contralateral eye.
Main safety outcome measures include best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were administered both hourly during the 8-hr study period and immediately following the study period.
There were no statistically significant changes in IOP, BCVA or TBUT immediately following the 8-hr study period or at the 1-week follow-up visit. Patient-reported tolerability was favorable with a mean response of 1.8 ± 0.4 (scale → 1=best, 10 = worst). Subjects also reported positive interest in the MPD as a glaucoma therapy with a mean response of 1.8 ± 0.5 (scale → 1=best, 10 = worst). One adverse event was reported (headache) and resolved at conclusion of the Day 0 visit.
The MPD demonstrated favorable safety with key parameters remaining stable after an 8-hr wear with negative pressure. Negative pressure application through the MPD was well tolerated by subjects enrolled in the study. The favorable findings demonstrate the safety of sustained delivery of negative pressure over a continuous, uninterrupted 8-hr duration.
研究多压力眼压计在开角型青光眼患者中持续使用8小时的安全性和耐受性。
前瞻性、对照、开放标签、随机、单中心研究。
10例开角型青光眼患者的20只眼睛佩戴多压力眼压计，并随机分为一组，一只眼睛施加-10 mmHg的负压8（连续）小时，对侧眼睛施加环境大气压。
主要安全性结局指标包括最佳矫正视力（BCVA）、负压施加后眼压（IOP）相对于基线的变化、裂隙灯和散瞳眼底检查结果以及不良事件发生率。在8小时的研究期间每小时以及研究期结束后立即进行主观评估。
在8小时研究期结束后或1周随访时，眼压、最佳矫正视力或泪膜破裂时间（TBUT）均无统计学上的显著变化。患者报告的耐受性良好，平均评分为1.8±0.4（评分标准→1=最佳，10=最差）。受试者还对多压力眼压计作为青光眼治疗方法表示出积极兴趣，平均评分为1.8±0.5（评分标准→1=最佳，10=最差）。报告了1例不良事件（头痛），在第0天访视结束时缓解。
多压力眼压计显示出良好的安全性，在施加负压8小时佩戴后关键参数保持稳定。参与研究的受试者对通过多压力眼压计施加负压耐受性良好。这些良好的结果证明了在连续、不间断的8小时内持续施加负压的安全性。
