Four Years Extended Follow-Up on CorVision® Bioengineered Corneal Microlens: Safety and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Uncorrected Near Visual Acuity of 0.3 logMAR or better
研究概览
简要总结
The objective of the study is to assess the long-term safety and effectiveness of the CorVision® microlens implanted in presbyopic patients for the management of management of presbyopia and near vision impairment. Approximately 100 patients in the Czech Republic will participate in this study. The study was reviewed and approved by an independent research ethics committee and also by the State Institute for Drug Control (SÚKL). The study will consist of a single visit during which standard, non-invasive, and painless examinations will be performed. This visit will correspond to the 4-year follow-up visit of the original clinical trial.
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 must have undergone implantation of CorVision microlens under study protocol CMG-PRT-
- •Provide informed consent
- •Willing to participate in the ophthalmological examinations
排除标准
- •Patients with severe ocular or general disorders that would prevent them from completed the visit.
- •Patients not being able to understand and give informed consent.
研究组 & 干预措施
Post-presbyopia correction with unilaterally implanted microlens
Presbyopic patients who have undergone implantation of the CorVision microlens according to study protocol CMG-PRT-002.
结局指标
主要结局
Uncorrected Near Visual Acuity of 0.3 logMAR or better
时间窗: At least 4 years after the implantation
More than 65% of the eyes should have an Uncorrected Near Visual Acuity (UNVA) of 0.3 logMAR or better at 4 years postoperatively.
Implant removal
时间窗: At least 4 years after the implantation
The incidence of implant rejection leading to implant removal should occur in no more than 3% of implanted eyes.
次要结局
- Clinically significant corneal haze occurrence(At least 4 years after the implantation)
研究者
Katerina Klimesova
Gemini Eye Clinic
Gemini Eye Clinic