Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Main outcome measures
研究概览
简要总结
To assess safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt for the treatment of primary open angle and exfoliative glaucomas.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects from 40 years up to 90 years old
- •Diagnosis of primary open angle glaucoma (POAG) and pseudo-exfoliative glaucoma
- •Subject is able to understand and sign a written informed consent form
- •Subject who underwent SST implantation and agreed to come for the cross-sectional follow-up
排除标准
- •Close angle forms of glaucoma
- •Congenital or developmental glaucoma
- •Pseudophakic with an anterior chamber intraocular lens (IOL), iris fixed IOL, or implantable contact lens (ICL)
- •Prior glaucoma procedures such as Selective Laser Trabeculoplasty (SLT), Microinvasive Glaucoma Surgery (MIGS) or Episcleral Shunts
- •History of corneal transplant, corneal refractive surgery, corneal dystrophy, or corneal ectasia (such as either keratoconus or keratoglobus) in the study eye
- •Chronic ocular inflammatory disease, or clinically significant ocular inflammation or infection (e.g., uveitis, iritis, iridocyclitis, retinitis).
- •Any condition that, in the Investigator´s opinion, can interfere with full participation in the study, including study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data.
结局指标
主要结局
Main outcome measures
时间窗: 1 month
A successful outcome was defined as Intraocular Pressure (IOP) reduction in ≥20%, with the IOP range 5-21mm/Hg. Successful outcomes were further categorized into two groups: Complete success - IOP reduction in ≥20%, with unmedicated the IOP range 5-21mm/Hg and Qualified success where reduction and ranges of IOP is the same but with antiglaucoma medications. Failure was defined as IOP reduction in \<20% or IOP \>21mm/Hg at last follow up. Permanent hypotony was defined as IOP \< 5mm/Hg during more than 4 weeks.
次要结局
未报告次要终点
研究者
Nikoloz Labauri
Founder and Managing Director, Principal Investigator
Davinci LTD