Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty, Randomized, Controlled Trial: iTrack (Nova Eye Medical) Compared to Omni (Sight Sciences)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 7
- 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
研究组 & 干预措施
iTrack canaloplasty microcatheter with Healon GV Pro
Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
干预措施: Canaloplasty using the iTrack microcatheter with Healon GV Pro (Device)
OMNI surgical system with Healon GV Pro
Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
干预措施: Canaloplasty using the Omni surgical system with Healon GV Pro (Device)
iTrack canaloplasty microcatheter with Healon Pro
Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
干预措施: Canaloplasty using the iTrack microcatheter with Healon Pro (Device)
OMNI surgical system with Healon Pro
Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
干预措施: Canaloplasty using the Omni surgical system with Healon Pro (Device)
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)