NCT04769453终止不适用
Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty, Randomized, Controlled Trial: iTrack (Nova Eye Medical) Compared to Omni (Sight Sciences)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention
研究概览
简要总结
A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with mild to moderate open angle Glaucoma.
- •Visual Field test (Humphrey SITA standard 24-2) with mean deviation better than or equal to -12.0 dB
- •IOP < or = to 36 mmHG while on one to four ocular hypotensive medications
- •Shaffer grade of > or = III in all four quadrants
- •Able and willing to comply with the Protocol and follow up visits for 12 months
排除标准
- •Laser trabeculoplasty other than selective laser trabeculoplasty (SLT)
- •History of iStent or iStent inject within 180 days of the screening visit
- •History of ECP or Micropulse laser
- •Trabeculectomy or other bleb forming procedure including Xen, Express and glaucoma drainage device/valves
- •Prior canaloplasty (ab interno and ab externo)
- •Prior goniotomy or trabeculotomy
- •History of Hydrus microstent or suprachoroidal stent
- •History of cataract surgery within 6 months of screening
- •Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary or pseudoexfoliative glaucoma
结局指标
主要结局
Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention
时间窗: 12 months
IOP will be measured at each study visit using Goldmann applanation tonometry
次要结局
- Complications intra-operatively and post-operatively associated with the iTrack canaloplasty microcatheter compared to complications intra-operatively and post-operatively with the OMNI surgical system.(12 months)
- Visual acuity at 12 months compared to baseline visual acuity(12 months)
研究者
研究点 (14)
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