使用OMNI手术系统(SightSciences,Inc)在轻度至中度开角型青光眼的假晶状体患者中。
回顾,多中心,在位于7个州的10个多专业眼科实践和手术中心进行的单臂研究(阿肯色州,加州,堪萨斯,路易斯安那州,密苏里州,纽约,和德克萨斯州)。
符合条件的患者是假晶状体,轻度/中度开角型青光眼,12个月随访,术前≤4种药物的药物眼压(IOP)≤36mmHg。每个患者招募一只眼睛。
机构审查委员会批准。所有符合资格标准的可用病例均被纳入。次要终点分析通过基线(BL)IOP(第1组>18mmHg和第2组≤18mmHg)分层,认识到治疗目标因BLIOP而异。
主要成功定义为在6至18mmHg(含6和18mmHg)之间,使用相同或更少的药物治疗而没有进行二次手术干预(SSI),患者IOP降低≥20%的患者比例。其他有效性终点包括12个月时的平均IOP和药物数量。安全终点是最佳矫正视力(BCVA),不良事件(AE),和SSIs。
48名患者入组,每组24。主要成功率为73%。第1组的平均眼压降低(21.8至15.6mmHg,P<0.0001),并在第2组(15.4至13.9mmHg,P=0.24)。第1组的药物治疗从1.7±1.3到1.2±1.3(P=0.024),第2组的药物治疗从2.0±1.3到1.3±1.3(P=0.003)。不良事件对于接受角度手术的患者人群是典型的。与手术合理相关的是轻度炎症(13%),IOP峰值(6%),前房积血,角膜水肿,和BCVA损失(全部4%)。五名患者(10%)需要SSI。
在患有开角型青光眼的假晶状体患者中,使用OMNI系统作为独立手术进行的泪管成形术和小梁切开术的序贯组合提供了有效的眼压降低或持续的眼压控制以及有意义的药物减少,持续12个月。
Provide outcomes up to 12 months postsurgically for sequential canaloplasty and trabeculotomy with the OMNI surgical system (Sight Sciences, Inc) in pseudophakic patients with mild to moderate open-angle glaucoma.
Retrospective, multicenter, single-arm
study conducted at 10 multi-subspecialty ophthalmology practices and surgery centers located in 7 states (Arkansas, California, Kansas, Louisiana, Missouri, New York, and Texas).
Eligible patients were pseudophakic, with mild/moderate open-angle glaucoma, 12-month follow-up, and medicated intraocular pressure (IOP) ≤36 mmHg on ≤4 medications preoperatively. One eye per patient was enrolled.
Institutional Review Board approved. All available cases meeting eligibility criteria were enrolled. Analysis of secondary end points was stratified by baseline (BL) IOP (>18 mmHg in group 1 and ≤18 mmHg in group 2) recognizing that treatment goals differed depending on BL IOP.
Primary success was defined as the proportion of patients with ≥20% reduction in IOP from BL or IOP between 6 and 18 mmHg (inclusive) and on the same or fewer medications without secondary surgical intervention (SSI). Other effectiveness end points included mean IOP and number of medications at 12 months. Safety end points were best-corrected visual acuity (BCVA), adverse events (AEs), and SSIs.
Forty-eight patients were enrolled, 24 in each group. Primary success was met by 73%. Mean IOP was reduced in group 1 (21.8 to 15.6 mmHg, P < 0.0001) and remained controlled in group 2 (15.4 to 13.9 mmHg, P = 0.24). Medications went from 1.7 ± 1.3 to 1.2 ± 1.3 (P = 0.024) in group 1 and from 2.0 ± 1.3 to 1.3 ± 1.3 (P = 0.003) in group 2. Adverse events were typical for the patient population undergoing angle surgery. Those reasonably related to the procedure were mild inflammation (13%), IOP spikes (6%), hyphema, corneal edema, and BCVA loss (all 4%). Five patients (10%) required an SSI.
The sequential combination of canaloplasty followed by trabeculotomy performed as stand-alone procedures using the OMNI system in pseudophakic patients with open-angle glaucoma provides effective IOP reduction or sustained IOP control and meaningful medication reduction for up to 12 months postoperatively.