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临床试验/NCT00876278
NCT00876278撤回4 期

Prospective Clinical Study to Evaluate Usability of Mesotest II for Assessment of Night Driving Capacity of Pseudophakic Patients Implanted With Monofocal IOL *AT.Smart 46LC

Carl Zeiss Meditec AG2 个研究点 分布在 1 个国家开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
试验地点
2
主要终点
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).

研究概览

简要总结

Pilot study to evaluate usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients implanted with aspheric monofocal posterior chamber IOL *AT.Smart 46LC.

Target Criterion:

Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy eyes with cataract
  • Patient age 50-75 years
  • Written Patient Informed Consent
  • Assured follow-up examination

排除标准

  • Any kind of macula degeneration and impairment of retina (clinical diagnosis)
  • Amblyopia
  • Intraoperative complications; damaged posterior bag; intraocular haemorrhage
  • Astigmatism > 1.5 D (objective, preoperative)
  • Pregnancy or lactation period for female patients

结局指标

主要结局

Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).

时间窗: 8 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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