Post-Market Evaluation of the EVO ICL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 8
- 主要终点
- Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg
研究概览
简要总结
The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).
详细描述
This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience and training to implant the EVO/EVO+ lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to high myopia correctable with available EVO ICL powers.
- •Moderate to high myopic with astigmatism correctable with available EVO ICL powers.
- •Stable refractive history within 0.50 D cylinder for 1 year prior to implantation.
- •Stable refractive history within 0.50 D for spherical equivalent 1 year prior to implantation.
- •Able and willing to return for scheduled follow-up examinations after surgery.
- •Able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Ocular hypertension or glaucoma.
- •Insulin dependent diabetes or diabetic retinopathy.
- •History of previous ocular surgery.
- •Monocular.
- •Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
EVO ICL
STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism.
干预措施: EVO ICL (Device)
结局指标
主要结局
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg
时间窗: 1-6 hours postoperatively
The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG
时间窗: 1-6 hours postoperatively
The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.
次要结局
- Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg(1-6 hours postoperatively)
- Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG(1-6 hours postoperatively)