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临床试验/NCT00635115
NCT00635115已完成不适用

The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia

Santéclair1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2006年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
127
试验地点
1
主要终点
patient preference for a corrective lens

研究概览

简要总结

The VEPRO trial is a cross-over randomised controlled trial comparing 2 corrective lenses for patients with presbyopia. The aim of the study is to compare the effectiveness of two corrective lenses: an old generation (Varilux Comfort Orma Crizal) and a new generation (Varilux Panamic Orma Crizal) of corrective lenses prescribed in presbyopia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
43 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age 43 to 60 years old
  • •outpatients wearing corrective lenses for presbyopia, referred to an optician within the last 6 months for a change in their optical correction
  • •associated hyperopia or astigmatism, the required correction had to be ≤ 3 dioptres in that case
  • •understanding, speaking French and able to answer a questionnaire

排除标准

  • •first prescription of corrective lenses for presbyopia
  • •associated strabism
  • •associated amblyopia
  • •orthoptics therapy
  • •associated anisometropia > 1.5 dioptres
  • •patients treated for diabetes

研究组 & 干预措施

1

Experimental

干预措施: a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal) (Device)

2

Active Comparator

干预措施: an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal) (Device)

结局指标

主要结局

patient preference for a corrective lens

时间窗: 8 weeks

次要结局

  • subjective measures of different areas of visual performance.(8 weeks)

研究者

发起方
Santéclair
申办方类型
Other

研究点 (1)

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