Toneatto Giacomo, Zeppieri Marco, Papa Veronica, Rizzi Laura, Salati Carlo, Gabai Andrea, Brusini Paolo
Department of Ophthalmology, University Hospital of Udine, 33100 Udine, Italy.
Department of Ophthalmology, Policlinico "Città di Udine", 33100 Udine, Italy.
J Clin Med. 2022 Jan 4;11(1):259. doi: 10.3390/jcm11010259.
To evaluate the effectiveness of ab-interno microcatheterization and 360° viscodilation of Schlemm's canal (SC) performed with OMNI viscosurgical system in open angle glaucoma (OAG) together or not with phacoemulsification.
Two surgical sites.
Retrospective, observational.
Eighty eyes from 73 patients with mild to moderate OAG underwent ab- interno SC viscodilation performed with OMNI system. Fifty eyes (Group 1) underwent only SC viscodilation, while 30 eyes (Group 2) underwent glaucoma surgery + cataract extraction. Primary success endpoint at 12 months was an intraocular pressure (IOP) reduction higher than 25% from baseline with an absolute value of 18 mmHg or lower, either on the same number or fewer ocular hypotensive medications, without further interventions. Secondary effectiveness endpoints included mean IOP, number of medications and comparison of outcomes between groups. Safety endpoints consisted of best-corrected visual acuity (BCVA), adverse events (AEs), and subsequent surgical procedures.
Primary success was achieved in 40.0% and 67.9% in Groups 1 and 2, respectively. Mean IOP at 12-month follow-up showed a significant reduction in both groups (from 23.0 to 15.6 mmHg, < 0.001, and from 21.5 to 14.1, < 0.001, in Groups 1 and 2, respectively). Mean medication number decreased in both groups (from 3.0 to 2.0, < 0.001 and from 3.4 to 1.9, < 0.001, in Groups 1 and 2, respectively). AEs included hyphema (2 eyes), mild hypotony (4 eyes), IOP spikes one month after surgery (1 eye). Twelve eyes (15.0%) required subsequent surgical procedures. No BCVA reduction was observed.
Viscodilation of SC using OMNI viscosurgical systems is safe and relatively effective in reducing IOP in adult patients with OAG.
评估使用OMNI粘弹手术系统进行施累姆氏管(SC)内微导管插入术和360°粘弹扩张术单独或联合白内障超声乳化术治疗开角型青光眼(OAG)的有效性。
两个手术地点。
回顾性观察研究。
73例轻至中度OAG患者的80只眼接受了使用OMNI系统进行的SC内粘弹扩张术。50只眼(第1组)仅接受了SC粘弹扩张术,而30只眼(第2组)接受了青光眼手术+白内障摘除术。12个月时的主要成功终点是眼压(IOP)较基线降低超过25%,绝对值为18 mmHg或更低,使用的降眼压药物数量相同或更少,且无需进一步干预。次要有效性终点包括平均IOP、药物数量以及组间结果比较。安全性终点包括最佳矫正视力(BCVA)、不良事件(AE)和后续手术。
第1组和第2组的主要成功率分别为40.0%和67.9%。12个月随访时两组的平均IOP均显著降低(第1组从23.0 mmHg降至15.6 mmHg,P<0.001;第2组从21.5 mmHg降至14.1 mmHg,P<0.001)。两组的平均用药数量均减少(第1组从3.0降至2.0,P<0.001;第2组从3.4降至1.9,P<0.001)。AE包括前房积血(2只眼)、轻度低眼压(4只眼)、术后1个月眼压峰值(1只眼)。12只眼(15.0%)需要后续手术。未观察到BCVA下降。
使用OMNI粘弹手术系统对SC进行粘弹扩张术在降低成年OAG患者的IOP方面是安全且相对有效的。