相关临床试验
4
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
1
25.0%
尚未招募
1
25.0%
终止
1
25.0%
撤回
1
25.0%
暂无批准数据
- The FDA has approved Ciliatech's Investigational Device Exemption application to launch a U.S. feasibility study of the INTERCIL Uveal Spacer in primary open-angle glaucoma. - The study is expected to enroll approximately 30 patients across three U.S. clinical sites, evaluating the device's safety and performance. - INTERCIL is a non-resorbable, 26% hydrophilic acrylic implant placed via an ab externo approach to restore uveoscleral outflow without entering the anterior chamber. - European SAFARI first-in-human data showed stable intraocular pressure control, with 95% of patients below 21 mmHg at 24 months and 90% free of prostaglandin medication.
- The FDA has granted 510(k) clearance to Rayner's Sophi phacoemulsification system, marking the first battery-based, wireless phaco system available for U.S. cataract surgeons. - The system features triple pump fluidics technology with IOP control, peristaltic, and Clean Venturi pumps designed to enhance anterior chamber stability and reduce contamination during cataract surgery. - Sophi's sustainable design includes reusable cassettes for up to 10 procedures and uses 75% less plastic than standard phaco machines, potentially reducing 307 kg of discarded plastic per 1,000 surgeries. - The wireless platform offers enhanced mobility and efficiency with integrated compressors, customizable settings, and an intuitive interface suited for ambulatory surgical centers and office-based practices.
- The FDA has approved Rayner's RayOne EMV Toric intraocular lens, marking a significant advancement in astigmatism correction for cataract patients. - Clinical trial results demonstrated exceptional rotational stability with 99% of eyes rotating ≤5° at 6 months, exceeding FDA requirements. - The lens features a patented non-diffractive optic design with controlled positive spherical aberration, delivering monofocal-level contrast sensitivity. - The approval follows successful completion of a multicenter FDA trial involving 238 patients comparing the toric IOL to a control monofocal lens.
