Ondrejka Simon, Körber Norbert, Dhamdhere Kavita
From the Augencentrum Köln, Köln, Germany (Ondrejka, Körber); Eye Clinic, University Eye Hospital, Padova, Italy (Körber); Sight Sciences, Menlo Park, California (Dhamdhere); Mahatma Gandhi Medical College and Research Center, Wardha, India (Dhamdhere).
J Cataract Refract Surg. 2022 Dec 1;48(12):1388-1393. doi: 10.1097/j.jcrs.0000000000001000. Epub 2022 Jul 1.
To assess the long-term safety and effectiveness of canaloplasty in reducing intraocular pressure (IOP) and use of IOP-lowering medications in eyes with open-angle glaucoma (OAG).
Surgical center (Augencentrum Köln, Köln, Germany).
Retrospective study.
206 eyes from 130 patients were included. Canaloplasty was performed using the VISCO360 or OMNI surgical system as a stand-alone procedure in 22 eyes and concomitantly with cataract extraction (CE) in 185 eyes with chronic OAG insufficiently controlled or intolerant to IOP-lowering medications. The number of hypotensive medications and IOP were recorded at baseline, day 1, week 1, month 1, month 3, and every 3 months thereafter, with the last follow-up visit at 36 ± 6 months postoperatively. Patients were stratified by baseline IOP (Group 1, IOP >18 mm Hg; Group 2, IOP ≤18 mm Hg). Treatment success in Group 1 was defined as a reduction in IOP and the use of IOP-lowering medications; Group 2 success was defined as maintenance of a lower IOP and a reduction in medication use.
The preoperative mean IOP of both groups was 21.1 ± 8.8 mm Hg, with a mean of 2.0 ± 0.9 hypotensive medications. The primary success end point was met by 73% of patients, with a mean IOP reduction in Group 1 (131 eyes; 21.8 to 15.6 mm Hg, P < .0001) and a maintenance of IOP control in Group 2 (76 eyes; 15.4 to 13.9 mm Hg, P = .24). Medications decreased from 2.2 ± 0.9 to 0.9 ± 1.1 in Group 1 ( P = .024) and from 1.8 ± 0.8 to 0.7 ± 1.0 in Group 2 ( P = .003).
Canaloplasty alone or in conjunction with CE with the VISCO360 or OMNI surgical system is a safe, tissue-sparing, and effective minimally invasive glaucoma surgery, using a clear corneal incision in phakic or pseudophakic eyes. Canaloplasty performed with both evaluated devices achieved statistically significant, consistent, and clinically meaningful reductions in IOP and use of IOP-lowering medications in adult patients with OAG. In the consistent cohort (n = 42), the IOP-lowering effect lasted up to 42 months, with ongoing data collection expected to describe long-term effectiveness of this intervention.
评估房角分离术降低开角型青光眼（OAG）患者眼压（IOP）及减少降眼压药物使用的长期安全性和有效性。
手术中心（德国科隆奥根森特鲁姆眼科中心）。
回顾性研究。
纳入130例患者的206只眼。采用VISCO360或OMNI手术系统单独进行房角分离术22只眼，在185只慢性OAG且眼压控制不佳或不能耐受降眼压药物的眼中与白内障摘除术（CE）同时进行。在基线、术后第1天、第1周、第1个月、第3个月及之后每3个月记录降压药物数量和眼压，术后最后一次随访在36±6个月。患者按基线眼压分层（第1组，眼压>18 mmHg；第2组，眼压≤18 mmHg）。第1组治疗成功定义为眼压降低和降眼压药物使用减少；第2组成功定义为维持较低眼压和药物使用减少。
两组术前平均眼压为21.1±8.8 mmHg，平均使用2.0±0.9种降压药物。73%的患者达到主要成功终点，第1组（131只眼；从21.8降至15.6 mmHg，P<.0001）眼压平均降低，第2组（76只眼；从15.4降至13.9 mmHg，P = .24）眼压维持在可控水平。第1组药物从2.2±0.9种降至0.9±1.1种（P = .024），第2组从1.8±0.8种降至0.7±1.0种（P = .003）。
单独或与CE联合使用VISCO360或OMNI手术系统进行房角分离术是一种安全、保留组织且有效的微创青光眼手术，在有晶状体或人工晶状体眼采用透明角膜切口。使用两种评估设备进行的房角分离术在成年OAG患者中使眼压和降眼压药物使用量实现了具有统计学意义、持续且有临床意义的降低。在连续队列（n = 42）中，眼压降低效果持续长达42个月，预期持续的数据收集将描述该干预措施的长期有效性。
