iStent Infinite and iDose TR for Management of Moderate to Severe Primary Open Angle Glaucoma Are a Safe and Effective Alternative to Filtering Surgery for IOP Reduction in Patients With Medically Uncontrolled Glaucoma. (POAG)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- IOP reduction from baseline
研究概览
简要总结
The Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled open angle glaucoma.
详细描述
The Investigators will assess the mean intraocular pressure change from baseline, the change in the number of medications from baseline, the proportion of patients needing additional incisional surgery, and the incidence of adverse events. The Investigators hypothesize that patients receiving the combined standalone iStent infinite and iDose will experience a safe and significant reduction in mean intraocular pressure and number of medications during the study time period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe open angle glaucoma (including POAG, PG, and PXG)
- •Open angle configuration (Shaffer grade ≥ 3), normal angle anatomy9
- •Visual acuity HM or better
- •VF MD -6dB or worse
- •Failed medical therapy and/or laser treatment
- •Incisional glaucoma surgery contemplated as next intervention
- •Phakic or pseudophakic
排除标准
- •Traumatic, uveitic, neovascular glaucoma, or angle closure glaucoma
- •Previous incisional glaucoma surgery
- •ALT; History of iridotomy, SLT, or micropulse laser trabeculoplasty within the prior 90 days
- •Active ocular inflammation or edema, clinically significant corneal dystrophy
- •Corneal or other pathology preventing accurate Goldmann applanation tonometry
研究组 & 干预措施
Surgery for patients with medically uncontrolled POAG
surgery using combined minimally invasive surgical iStent infinite trabecular micro-bypass systme model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg
干预措施: iStent infinite trabecular micro-bypass system model iS3 (Device)
Surgery for patients with medically uncontrolled POAG
surgery using combined minimally invasive surgical iStent infinite trabecular micro-bypass systme model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg
干预措施: iDose TR (Travoprost intracameral Implant) 75mcg (Drug)
结局指标
主要结局
IOP reduction from baseline
时间窗: Diurnal IOP reduction from baseline at 12 months
a logistic regression model will be used for the imputation of missing values, using the 12-month performance outcome as dependent variable, and sex, race, age, baseline IOP, number of IOP-lowering medications used at baseline, last IOP and number of medications at the 6-month visit or later as explanatory variables.
次要结局
未报告次要终点
研究者
Jonathon Myers
Co-Investigator
Wills Eye