NCT02394379已完成不适用
A Prospective, Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber Intraocular Lens (IOL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of clinically significant IOL vaulting
研究概览
简要总结
To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery.
详细描述
The objective of this post approval safety study is to evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery at up to three years post implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are able and willing to comply with the follow-up schedule
- •Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction
- •Subjects must require a lens power from 4 to 33 D
- •Subjects must have a Best Corrected Visual Acuity (BCVA) equal to or worse than 20/40, with or without a glare source
排除标准
- •Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery
- •Subjects with associated ocular conditions which could affect the stability of the IOL
- •Subjects with clinically significant irregular corneal astigmatism in the study eye
结局指标
主要结局
Incidence of clinically significant IOL vaulting
时间窗: Up to 3 years
IOL vaulting is position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting. The proportion of study eyes experiencing vaulting will be estimated by Kaplan-Meier method.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Post-Approval Study of the Tecnis® Toric IOLCataractNCT02566083Abbott Medical Optics365
已完成
不适用
Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)CataractAstigmatismNCT02649842Abbott Medical Optics101
尚未招募
不适用
clinical evaluation and comparision of toric IOL rotational stability when implanted under Balanced salt solutionvs Ophthalmic viscosurgical devicesCTRI/2020/01/023077ethradhama superspeciality eye hospital
已完成
不适用
STAAR Visian Toric ICL Post-Approval StudyMyopic AstigmatismNCT04516772Staar Surgical Company125
Unknown
4 期
Clinical Evaluation of Toric Intraocular Lens Made by AurolabAstigmatismNCT01396616Aurolab120