NCT02203747已完成不适用
Patient Perception of Visual Distortions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Visual Distortion Symptoms
研究概览
简要总结
The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Corneal astigmatism of at least 0.75 diopters
- •Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes
- •At least one month postoperative from second-eye surgery
- •Ability to understand, read and write English to give consent and complete study questionnaire
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
- •Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms
- •Patient is pregnant or is lactating
- •Participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Visual Distortion Symptoms
时间窗: 1 week
Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.
次要结局
未报告次要终点
研究者
研究点 (1)
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