Radcliffe Nathan M, Harris Jennifer, Garcia Kristian, Zwick Erin, Chang Robert T, Mbagwu Michael
Mt Sinai School of Medicine (N.M.R), New York, New York, USA..
Verana Health (J.H., K.G, E.Z., R.T.C.), San Francisco, California, USA.
Am J Ophthalmol. 2025 Mar;271:436-444. doi: 10.1016/j.ajo.2024.12.015. Epub 2024 Dec 24.
To characterize long-term real-world clinical outcomes of standalone canaloplasty and trabeculotomy using the OMNI Surgical System (Sight Sciences) in patients with primary open-angle glaucoma (POAG).
Retrospective, clinical cohort study utilizing the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) data.
Patients/eyes in the IRIS Registry with POAG or ocular hypertension with known laterality on or after January 1, 2016 and undergoing standalone canaloplasty and trabeculotomy using the OMNI Surgical System with at least 6 months and up to 36 months of postoperative follow-up were included. Eyes were excluded for prior filtration surgery, trabeculoplasty within 90 days of the OMNI procedure, or concomitant cataract surgery.
METHODS/OUTCOME MEASURES: Outcome measures included intraocular pressure (IOP) and glaucoma medication changes postoperatively.
230 eyes in 196 patients were analyzed. Most eyes had moderate (40.0 %) or severe (41.3 %) POAG. Two-thirds (153 of 230) were pseudophakic. Fewer than half of procedures (44.4 %) were performed by glaucoma specialists. Mean baseline IOP was 22.1 (6.4) mmHg and over 36 months of follow-up ranged from 15.1 to 16.7 mmHg (p < 0.0001 at every time point compared to baseline), with average eye-level reductions of 5.6-7.1 mmHg. The mean number of glaucoma medications used at baseline was 2.1 (1.5) and over 36 months ranged from 1.1 to 1.8 medication classes, with statistically significant decreases in utilization through 18 months postoperatively (p ≤ 0.0011) and nonsignificant at months 24 and 36. Eyes with lower baseline IOP (≤18 mmHg) had reductions in medication use through 36 months, and eyes with higher baseline IOP (>18 mmHg) had statistically significant reductions in IOP through 36 months.
Standalone canaloplasty and trabeculotomy provides clinically and statistically significant reductions in IOP through up to 36 months postoperatively. Eyes with lower baseline IOP had long-term glaucoma medication reductions and eyes with higher baseline IOP had statistically significant long-term IOP reductions. Standalone OMNI surgery is a reasonable MIGS option for patients with POAG seeking IOP reduction, medication reduction, or both.
使用OMNI手术系统（视觉科学公司）对原发性开角型青光眼（POAG）患者进行单独的小梁切开术和房角成形术，以描述其长期的真实世界临床结果。
利用美国眼科学会IRIS®注册中心（视力智能研究）的数据进行回顾性临床队列研究。
IRIS注册中心中2016年1月1日及以后患有POAG或高眼压症且已知患侧、接受使用OMNI手术系统进行单独小梁切开术和房角成形术、术后随访至少6个月至36个月的患者/眼睛。排除曾接受过滤过手术、在OMNI手术90天内进行过小梁成形术或同时进行白内障手术的眼睛。
方法/观察指标：观察指标包括术后眼压（IOP）和青光眼药物使用情况的变化。
分析了196例患者的230只眼睛。大多数眼睛患有中度（40.0%）或重度（41.3%）POAG。三分之二（230只中的153只）为人工晶状体眼。不到一半的手术（44.4%）由青光眼专科医生进行。平均基线眼压为22.1（6.4）mmHg，在36个月的随访期间眼压范围为15.1至16.7 mmHg（与基线相比，每个时间点p<0.0001），平均眼压降低5.6 - 7.1 mmHg。基线时使用的青光眼药物平均数量为2.1（1.5）种，在36个月期间为1.1至1.8种药物类别，术后18个月内药物使用量有统计学显著下降（p≤0.0011），在24个月和36个月时无显著下降。基线眼压较低（≤18 mmHg）的眼睛在36个月内药物使用量减少，基线眼压较高（>18 mmHg）的眼睛在36个月内眼压有统计学显著下降。
单独的小梁切开术和房角成形术在术后长达36个月内可使眼压在临床和统计学上显著降低。基线眼压较低的眼睛长期青光眼药物使用量减少，基线眼压较高的眼睛眼压有统计学显著的长期降低。对于寻求降低眼压、减少药物使用或两者兼有的POAG患者，单独的OMNI手术是一种合理的微侵袭性青光眼手术选择。
