Sarkisian Steven R, Mitchell Evann C
Research & Clinical Trials, Oklahoma Eye Surgeons, Oklahoma City, OK, USA.
College of Medicine, University of Oklahoma, Oklahoma City, OK, USA.
Clin Ophthalmol. 2024 Mar 23;18:917-927. doi: 10.2147/OPTH.S452159. eCollection 2024.
To assess the effectiveness and safety of bimatoprost sustained release (SR) glaucoma implant as a treatment for open-angle glaucoma and ocular hypertension in a real-world private practice setting with a significant American Indian population.
This retrospective study included 156 eyes from adult patients who received a single injection of bimatoprost implant between June 2020 and May 2022 at the Oklahoma Eye Surgeons. Patients were stratified by baseline intraocular pressure (IOP) (≥21 mmHg versus IOP<21 mmHg). The co-primary endpoints were changes in the mean IOP and the number of topical IOP-lowering medications from baseline to Month 6.
At 6 months, eyes with baseline IOP≥21 mmHg had a significantly lower mean IOP (19.85±8.01 versus 26.25±4.84 mmHg; p<0.0001) and the mean number of IOP-lowering medications (1.04±1.44 versus 1.38±1.50; p=0.048) compared with baseline. One year after implantation, 73.58% of eyes had a ≥20% reduction in IOP, 41.51% were medication-free and 30.19% were receiving at least one fewer medication. Among eyes with baseline IOP<21 mmHg, there was a significant reduction in the mean number of IOP-lowering medicines by Month 6 (0.61±1.03 versus 1.93±1.21 at baseline; p<0.0001), with no change in IOP. At 12 months, 24.27% of eyes had a ≥20% decrease in IOP, 43.69% of eyes did not require any medications and 63.11% had at least one fewer medication compared with baseline. An analysis using Welch's two-sample -test showed no significant differences in the outcomes between the overall population and the American Indian population (number of eyes, 23).
Bimatoprost SR glaucoma implant lowered IOP in eyes with high, uncontrolled baseline IOP, while it reduced the number of medications in eyes with a controlled baseline IOP. No clinically meaningful and statistically significant differences in the efficacy of bimatoprost were observed in patients of American Indian descent.
在一个有大量美国印第安人口的现实世界私人诊所环境中，评估比马前列素缓释（SR）青光眼植入物治疗开角型青光眼和高眼压症的有效性和安全性。
这项回顾性研究纳入了2020年6月至2022年5月期间在俄克拉荷马眼科医生诊所接受单次比马前列素植入注射的成年患者的156只眼睛。患者按基线眼压（IOP）分层（≥21 mmHg与IOP<21 mmHg）。共同主要终点是从基线到第6个月平均IOP的变化以及局部降眼压药物的数量。
在6个月时，基线IOP≥21 mmHg的眼睛与基线相比，平均IOP显著降低（19.85±8.01对26.25±4.84 mmHg；p<0.0001），降眼压药物的平均数量也显著降低（1.04±1.44对1.38±1.50；p=0.048）。植入后一年，73.58%的眼睛IOP降低了≥20%，41.51%的眼睛无需用药，30.19%的眼睛用药至少减少一种。在基线IOP<21 mmHg的眼睛中，到第6个月时降眼压药物的平均数量显著减少（基线时为0.61±1.03对1.93±1.21；p<0.0001），而IOP没有变化。在12个月时，24.27%的眼睛IOP降低了≥20%，43.69%的眼睛不需要任何药物，63.11%的眼睛用药比基线时至少减少一种。使用韦尔奇两样本t检验的分析表明，总体人群和美国印第安人群（眼睛数量为23只）之间的结果没有显著差异。
比马前列素SR青光眼植入物可降低基线IOP高且未得到控制的眼睛的IOP，同时减少基线IOP得到控制的眼睛的药物数量。在美洲印第安血统患者中，未观察到比马前列素疗效有临床意义和统计学上的显著差异。
