ViaLase Initiates First U.S. IDE Trial Patient Treatment for Incision-Free Glaucoma Laser Procedure

通过Vialase启动了美国首个IDE试验患者治疗，用于无切口青光眼激光手术。

December 04, 2025

2025年12月4日

ViaLase has announced the treatment of the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial, marking a major milestone in the development of its femtosecond laser trabeculotomy procedure, a novel, incision-free approach for the treatment of glaucoma.

ViaLase 宣布其在美国研究器械豁免 (IDE) 临床试验中已治疗首位患者，这标志着其飞秒激光小梁切除术在开发上迈出了重要一步，该技术是一种治疗青光眼的创新无切口方法。

Evaluating a New Laser-Based Alternative to SLT

评估一种新的基于激光的SLT替代方案

The prospective, multicenter, randomized, controlled trial is designed to compare the ViaLase procedure with selective laser trabeculoplasty (SLT), which is currently the standard laser therapy for reducing intraocular pressure (IOP) in glaucoma patients. Developed in consultation with the U.S. Food and Drug Administration (FDA), the pivotal IDE trial is structured to support future regulatory clearance and commercialization in the United States..

这项前瞻性、多中心、随机、对照试验旨在比较ViaLase手术与选择性激光小梁成形术（SLT），后者是目前用于降低青光眼患者眼内压（IOP）的标准激光疗法。该关键IDE试验是在与美国食品药品监督管理局（FDA）协商后设计的，旨在为未来在美国的监管审批和商业化提供支持。

Clinical Significance and Potential Impact

临床意义与潜在影响

Thomas W. Samuelson, MD, founding partner and attending surgeon at Minnesota Eye Consultants and medical monitor of the trial, emphasized the importance of this milestone:

托马斯·W·塞缪尔森医学博士，明尼苏达眼科顾问公司的创始合伙人兼主刀医生，同时也是该项试验的医学监督员，他强调了这一里程碑的重要性：

“Treating the first patient in this trial is a significant milestone, not only for ViaLase, but for the broader glaucoma community. For the first time, we will have randomized data comparing a next-generation incision-free canal procedure against SLT. The results have the potential to reshape the glaucoma treatment paradigm as physicians and patients are increasingly seeking incision-free, non-pharmacologic pressure-lowering therapies that are safe, effective, and durable.”.

“在这项试验中治疗首位患者是一个重要的里程碑，这不仅是对ViaLase而言，对于更广泛的青光眼群体也是如此。我们将首次获得随机数据，比较下一代无切口小梁切除术与选择性激光小梁成形术（SLT）。这些结果有可能重塑青光眼的治疗模式，因为医生和患者越来越倾向于寻找安全、有效且持久的无切口、非药物降压疗法。”

Precision-Based, Noninvasive Approach to Glaucoma Management

基于精确性的青光眼无创管理方法

ViaLase’s femtosecond laser trabeculotomy is designed to target the eye’s natural drainage pathway with a precise, noninvasive laser, aiming to lower IOP without surgical incisions. This innovative approach may offer a safer and less invasive alternative to existing glaucoma treatments, aligning with current trends toward non-pharmacologic, minimally invasive therapies..

ViaLase的飞秒激光小梁切除术旨在通过精确的非侵入性激光靶向眼睛的自然引流路径，以降低眼压而无需手术切口。这种创新方法可能为现有的青光眼治疗提供更安全、更少侵入性的替代方案，符合当前趋向于非药物、微创治疗的趋势。

Strategic Vision for the Future of Glaucoma Treatment

青光眼治疗的未来战略愿景

Shawn O’Neil, CEO of ViaLase, commented on the significance of the IDE trial as part of the company’s broader mission:

肖恩·奥尼尔，ViaLase首席执行官，就IDE试验的重要性发表评论，作为公司更广泛使命的一部分：

“Our mission at ViaLase is to develop a new approach to manage IOP in patients with glaucoma. This IDE trial is an important step toward making the ViaLase procedure broadly available to the millions of glaucoma patients in need. We believe our technology has the potential to begin an entirely new era in glaucoma care, one where precision, safety, and the patient experience define the standard of treatment.”.

“我们在ViaLase的使命是开发一种管理青光眼患者眼压的新方法。这项IDE试验是让ViaLase手术广泛应用于数百万需要的青光眼患者的重要一步。我们相信，我们的技术有潜力开启青光眼治疗的全新时代，一个以精确性、安全性和患者体验定义治疗标准的时代。”