Goldberg Jeffrey L, Jiminez-Roman Jesus, Hernandez-Oteyza Alejandra, Quiroz-Mercado Hugo
Byers Eye Institute, Stanford University, Stanford, CA, USA.
Glaucoma Department, APEC, Mexico City, MX, USA.
Ophthalmol Ther. 2021 Jun;10(2):349-358. doi: 10.1007/s40123-021-00343-4. Epub 2021 Apr 19.
The purpose of this study was to investigate the short-term safety and feasibility of negative pressure application by the Multi-Pressure Dial (MPD) System to lower nocturnal intraocular pressure (IOP) in subjects with open-angle glaucoma (OAG).
A prospective, controlled, intra-subject study of 22 eyes from 11 subjects at a single site was performed. All subjects had a history of OAG and were currently using a topical prostaglandin. For each subject, the eye with the highest IOP in the supine position was selected as the treatment eye (TE) and the contralateral eye served as the control eye (CE). The negative pressure for the TE was set to 60% of the baseline IOP value with no negative pressure in the CE. IOP measurements were collected at three prespecified time points overnight in the supine position with active negative pressure. The primary outcome measure was mean IOP with the application of negative pressure.
At the three overnight time points, the mean (± standard deviation) baseline IOP prior to negative pressure application was 22.2 ± 2.5 mmHg in the TE and 21.8 ± 2.5 mmHg in the CE. With the application of 60% negative pressure to the TE and no active negative pressure to the CE, the mean IOP was 14.2 ± 2.2 and 19.5 ± 2.4 mmHg, respectively. The mean percentage IOP reduction in the TE was 35% (p < 0.001). There were two minor adverse events, both unrelated to device wear, and there were no IOP spikes ≥ 10 mmHg.
The MPD can safely and effectively lower nocturnal IOP in the supine position. The MPD holds promise as a potential new, non-invasive treatment option for the control of nocturnal IOP.
本研究旨在探讨多压力透析（MPD）系统施加负压降低开角型青光眼（OAG）患者夜间眼压（IOP）的短期安全性和可行性。
在单一研究地点对11名受试者的22只眼睛进行了一项前瞻性、对照、受试者自身对照研究。所有受试者均有OAG病史，目前正在使用局部前列腺素类药物。对于每个受试者，仰卧位眼压最高的眼睛被选为治疗眼（TE），对侧眼作为对照眼（CE）。TE的负压设置为基线眼压值的60%，CE不施加负压。在仰卧位且处于主动负压状态下，于夜间三个预先设定的时间点收集眼压测量值。主要观察指标为施加负压时的平均眼压。
在夜间三个时间点，TE在施加负压前的平均（±标准差）基线眼压为22.2±2.5 mmHg，CE为21.8±2.5 mmHg。对TE施加60%的负压，CE不施加主动负压时，平均眼压分别为14.2±2.2 mmHg和19.5±2.4 mmHg。TE的平均眼压降低百分比为35%（p<0.001）。发生了两起轻微不良事件，均与设备佩戴无关，且未出现眼压升高≥10 mmHg的情况。
MPD可安全有效地降低仰卧位时的夜间眼压。MPD有望成为一种控制夜间眼压的潜在新型非侵入性治疗选择。
