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临床试验/NCT04516772
NCT04516772已完成不适用

Post-Approval Study of the Visian Toric Implantable Collamer Lens

Staar Surgical Company8 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2020年7月21日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
8
主要终点
Change in Axis Orientation of the TICL
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL).

详细描述

This study will be conducted at 6-8 clinical sites in the US, by surgeons qualified by experience and training to implant Visian Toric ICLs.

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 with astigmatism correctable with available TICL powers.
  • •Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 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

  • •Insulin-dependent diabetes or diabetic retinopathy.
  • •History of previous ocular surgery.
  • •Cataract of any grade.
  • •Monocular.
  • •Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.
  • •Other protocol-specified exclusion criteria may apply.

研究组 & 干预措施

Visian TICL

Other

STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism.

干预措施: Visian TICL (Device)

结局指标

主要结局

Change in Axis Orientation of the TICL

时间窗: 18 to 24 months postoperative

Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative

次要结局

  • Manifest Refraction Cylinder at Month 18(Month 18)
  • Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1)(Day 1 (1-2 days postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1)(Week 1 (5-9 days postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1)(Month 1 (3-5 weeks postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3)(Month 3 (10-14 weeks postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6)(Month 6 (21 - 26 weeks postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12)(Month 12 (11 - 14 months postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18)(Month 18 (17 - 21 months postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24)(Month 24 (23 - 27 months postoperatively))
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)(Operative Visit)
  • Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)(Day 1 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)(Week 1 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)(Month 1 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)(Month 3 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)(Month 6 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)(Month 12 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)(Month 18 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)(Month 24 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit)(Operative Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit)(Day 1 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit)(Week 1 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit)(Month 1 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit)(Month 3 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit)(Month 6 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit)(Month 12 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit)(Month 18 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit)(Month 24 Visit)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 1(Month 1)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 3(Month 3)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 6(Month 6)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 12(Month 12)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 18(Month 18)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 24(Month 24)
  • Manifest Refraction Cylinder at Month 1(Month 1)
  • Manifest Refraction Cylinder at Month 3(Month 3)
  • Manifest Refraction Cylinder at Month 6(Month 6)
  • Manifest Refraction Cylinder at Month 12(Month 12)
  • Manifest Refraction Cylinder at Month 24(Month 24)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (8)

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