Ferguson Tanner J, Radcliffe Nathan M, Van Tassel Sarah H, Baartman Brandon J, Thompson Vance M, Lindstrom Richard L, Ibach Mitch J, Berdahl John P
Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA.
New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA.
Clin Ophthalmol. 2020 Sep 21;14:2739-2746. doi: 10.2147/OPTH.S256891. eCollection 2020.
To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days.
Prospective, open-label, randomized, single-site study.
Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of -10 mmHg in one eye (study eye) worn overnight for 7 consecutive days.
Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period.
Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean IOP from 18.2 ± 3.8 mmHg to 14.0 ± 2.1 mmHg (p<0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 ± 4.3 mmHg to 13.5 ± 3.7 mmHg. The observed IOP reduction was in addition to the subjects' current treatment regimen. There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable.
The MPD can safely and comfortably be worn overnight. The decrease in IOP of >20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.
研究连续7天夜间佩戴多压力眼压计（MPD）的安全性和耐受性。
前瞻性、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MPD，并随机分为一只眼睛（研究眼）施加-10 mmHg的负压，连续7天夜间佩戴。
安全指标包括最佳矫正视力（BCVA）、负压施加期间及之后眼压（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。在为期7天的研究期间，受试者每天完成主观评估，并在研究期结束后立即进行评估。
在7天测试期之前，施加10 mmHg负压可使平均眼压从18.2±3.8 mmHg降至14.0±2.1 mmHg（p<0.01），降低了22%。连续7天夜间佩戴后，再次测量施加负压时的眼压，结果显示平均眼压从16.9±4.3 mmHg降至13.5±3.7 mmHg。观察到的眼压降低是在受试者当前治疗方案基础上的额外降低。在连续7天夜间佩戴负压装置后，眼压和BCVA相对于基线均无统计学显著变化。患者报告的结果良好。
MPD可以安全舒适地夜间佩戴。除当前治疗外，眼压降低>20%在临床和统计学上均具有显著意义。MPD有望成为夜间眼压控制的一种潜在新治疗选择。
