A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Eearly Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score
研究概览
简要总结
Age related cataracts are responsible for about 51 percent of blindness worldwide and according to the WHO affect about 20 million people, according to the WH . As cataract surgery is firstline treatment in the western world, there is a constant attempt to improve artificial intraocular lenes (IOL).
As for this study, the investigators seek to compare four different IOL designs in in a psychophysiological setting, allowing to assess the impact of these IOLs on vision and psychological processing of visual information.
As these IOLs also have downsides, such as reduced light intensity or image alterations, the subjective preference and overall impression shall be investigated. The healthy subjects look through a stable spectacle frame mounted onto a table, which enables the investigator to insert the different IOLs. This would allow subjective testing of IOLs before surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 18 and 35 years
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings, between -1 and +1 diopters
排除标准
- •> 0,5 diopters of cylinder
- •Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
研究组 & 干预措施
30 healthy male and female subjects
30 healthy male and female subjects aged 18-35
干预措施: Cyclopentolatehydrochloride (Drug)
结局指标
主要结局
Eearly Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score
时间窗: 1 study day
To investigate the psychophysiological impact of different optical setups on visual acuity at far, intermediate and near distance.
次要结局
未报告次要终点
研究者
Gerhard Garhofer
assoc. Prof. Dr.med.univ.
Medical University of Vienna