Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Thomas Nagy
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Binocular distance-corrected visual acuity at distance (6m)
研究概览
简要总结
The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.
详细描述
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Binocular distance-corrected visual acuity at distance (6m)
时间窗: 3 months postoperative
Binocular distance-corrected visual acuity at intermediate (66cm)
时间窗: 3 months postoperative
次要结局
- Percentage of eyes with absolute prediction error less than or equal to 0.50D(3 months postoperative)
- Percentage of eyes with refractive astigmatism less than or equal to 0.50 D(3 months postoperative)
研究者
Thomas Nagy
Principal Investigator
Vision North Eye Centre