Lazcano-Gomez Gabriel, Orlich Claudio, Batlle Juan F, Ison Elysia M, Reynolds Heather P, Harbin Med, Kahook Malik Y
Department of Glaucoma, Clínica Laser y Ultrasonido Ocular, Puebla City, Mexico.
Clinica 20/20, San José, Costa Rica.
Clin Ophthalmol. 2024 Dec 27;18:3967-3976. doi: 10.2147/OPTH.S473981. eCollection 2024.
To report the 12-month clinical outcomes in eyes with mild to moderate open-angle glaucoma (OAG) in Hispanic adults undergoing STREAMLINE Surgical System (STREAMLINE) canaloplasty combined with phacoemulsification.
This was a prospective, multi-center, interventional clinical trial involving 45 eyes of 45 Hispanic adult patients receiving topical medical therapy for mild to moderate OAG and undergoing phacoemulsification surgery for visually significant cataracts at three sites. All eyes underwent a Screening visit, followed by medication washout and a subsequent Baseline visit to determine eligibility for STREAMLINE canaloplasty. The primary outcome was the proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20% from Baseline at Month 12. Secondary outcomes included mean change in IOP from post-washout Baseline, mean change in IOP-lowering medications compared to pre-washout Screening, and adverse events (AEs).
43 eyes met the eligibility criteria for analysis and 40 eyes completed the 12-month visit. The mean (standard deviation) age was 68.7 (8.6 years), 76.7% were female, and 72.1% of the eyes were classified as having mild OAG. The mean number of IOP-lowering medications at Screening was 1.95 (0.82). After washout, the Baseline mean IOP was 23.0 (1.8) mmHg. At Month 12, 28/40 eyes (70.0%) remained medication-free, of which 27 (96.4%) had an IOP reduction of ≥20% from Baseline. The mean IOP at Month 12 was 15.3 (2.8) mmHg, a reduction of 7.8 (3.0) mmHg from Baseline (p<0.001). The mean medication use at Month 12 was 0.63 (1.19) per eye, representing a mean reduction of 1.38 (1.03) medications from Screening (p<0.001). Device- or procedure-related ocular AEs were mostly mild in severity and self-limited.
STREAMLINE canaloplasty in combination with phacoemulsification provides clinically and statistically significant reduction in IOP and IOP-lowering medications in eyes with mild to moderate OAG in Hispanic adults.
报告西班牙裔成年人中，接受STREAMLINE手术系统（STREAMLINE）小梁切开术联合超声乳化术治疗的轻至中度开角型青光眼（OAG）患者12个月的临床结果。
这是一项前瞻性、多中心、干预性临床试验，涉及45名西班牙裔成年患者的45只眼睛，这些患者在三个地点接受轻至中度OAG的局部药物治疗，并因明显影响视力的白内障接受超声乳化手术。所有眼睛均接受一次筛查访视，随后进行药物洗脱，以及后续的基线访视，以确定是否适合进行STREAMLINE小梁切开术。主要结局是在第12个月时，眼压（IOP）从基线降低≥20%且未使用药物的眼睛比例。次要结局包括从洗脱后基线开始的IOP平均变化、与洗脱前筛查相比降低IOP药物的平均变化，以及不良事件（AE）。
43只眼睛符合分析的纳入标准，40只眼睛完成了12个月的访视。平均（标准差）年龄为68.7（8.6岁），76.7%为女性，72.1%的眼睛被分类为轻度OAG。筛查时降低IOP药物的平均数量为1.95（0.82）。洗脱后，基线平均IOP为23.0（1.8）mmHg。在第12个月时，28/40只眼睛（70.0%）仍未使用药物，其中27只（96.4%）的IOP较基线降低≥20%。第12个月时的平均IOP为15.3（2.8）mmHg，较基线降低了7.8（3.0）mmHg（p<0.001）。第12个月时每只眼睛的平均药物使用量为0.63（1.19），相较于筛查时平均减少了1.38（1.03）种药物（p<0.001）。与设备或手术相关的眼部AE大多严重程度较轻且为自限性。
STREAMLINE小梁切开术联合超声乳化术可使西班牙裔成年人轻至中度OAG患者的IOP及降低IOP的药物使用在临床和统计学上显著减少。
