NCT01131481撤回4 期
Evaluation of Glistenings in Intraocular Lenses AVS Model X-60 Vs AcrySof MA50-BM.
Fry Eye Associates and Fry Eye Surgery Center2 个研究点 分布在 1 个国家开始时间: 2010年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Evaluation of Glistenings between the Model X-60 made by the AVS company and AcrySof MA50BM made by the Alcon company.
研究概览
简要总结
Evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs AcrySof MA50BM made by the Alcon company.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Bilateral cataracts requiring surgery
- •Potential visual acuity of 20/40 or better in both eyes
- •Require IOL power in range of 15-25 diopters
- •Pupillary dilation of at least 6mm
- •Willing and able to provide informed consent and attend follow-up appointments to 3 years
排除标准
- •Any co-existing ocular disease or previous ocular surgery that would confound findings in the study, especially those effecting quality of vision. Examples include Macular degeneration amblyopia and prior epiretinal membrane peel.
结局指标
主要结局
Evaluation of Glistenings between the Model X-60 made by the AVS company and AcrySof MA50BM made by the Alcon company.
时间窗: The patient will be followed 1-2 days after surgery on the first eye and 1-2 days after surgery on the second eye,1-2 months after surgery on both eyes,4-6 months after surgery on both eyes and 1,2 and 3 yrs after surgery on both eyes.
Each patient will have the same testing at each visit. Photos will be taken of the glistenings,sent off and counted.
次要结局
未报告次要终点
研究者
研究点 (2)
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