NCT04967612已完成不适用
Evaluation of Visual Perception Through Diffractive Optical Lens Designs by Virtual Implantation.
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
- 74
- 试验地点
- 1
- 主要终点
- Corrected distance visual acuity
研究概览
简要总结
Evaluation of visual perception through diffractive optical lens designs by virtual implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects between and including 18 and 50 years of age;
- •Healthy eyes;
- •Dominant eye with a monocular CDVA ≥1.0 decimal (≤ 0.0 logMAR) without cycloplegia;
- •Subject who has been informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
- •Negative COVID19 screening test prior to every trial visit.
排除标准
- •Subjects of less than 18 or more than 50 years of age;
- •Monocular CDVA of dominant eye < 1.0 decimal (> 0.0 logMAR) without cycloplegia;
- •Subject unable to comply with the study protocol or likely to be non-cooperative during the study;
- •Subject whose freedom is impaired by administrative or legal issues, or adult persons under legal protection or unable to give an informed consent;
- •Pseudophakic subjects;
- •Subjects, who are unable to fixate for a longer time, e.g. strabismus, nystagmus;
- •Pathologic miosis;
- •Intake of drugs affecting vision;
- •Participation in another biomedical study in parallel, if it affects vision or if interactions with cycloplegia exist;
- •Intolerance to or contraindication to cycloplegia, e.g. due to narrow angle of the anterior ocular chamber;
- •Hyperopes with more than +6 D refraction.
研究组 & 干预措施
Virtual implantation of diffractive optical lens design A
Experimental
干预措施: Virtual implantation (Other)
Virtual implantation of diffractive optical lens design B
Experimental
干预措施: Virtual implantation (Other)
Virtual implantation of diffractive optical lens design C
Experimental
干预措施: Virtual implantation (Other)
结局指标
主要结局
Corrected distance visual acuity
时间窗: during the intervention
Evaluate visual acuity at distance following virtual implantation of diffractive optical lens designs
次要结局
未报告次要终点
研究者
研究点 (1)
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