Spectacle Independence After Implantation of Trifocal and Trifocal Toric Intraocular Lenses Using Intraoperative Aberrometry: A Prospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of spectacle independence (overall)
研究概览
简要总结
The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Able to consent to study and cataract surgery
- •Visually significant cataract
- •Potential post-operative visual acuity of 20/25 or better
- •Age 18 years or older
排除标准
- •Ocular pathology contraindicated for trifocal IOLs including but not limited to diabetic retinopathy, age-related macular degeneration or other macular pathology, cornea guttata, corneal scarring, corneal ectasia, glaucoma with visual field loss
- •Irregular astigmatism
- •Prior corneal refractive surgery
结局指标
主要结局
Percentage of spectacle independence (overall)
时间窗: 1 month post-cataract surgery
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Percentage spectacle independence (overall)
时间窗: 3 months post-cataract surgery
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
次要结局
- Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)(3 months post-cataract surgery)
- Distribution of residual refractive error(3 months post-cataract surgery)
- Spectacle independence for distance, intermediate and near(3 months post-cataract surgery)
- Percentage of subjects with <=0.50 D of refractive cylinder(3 months post-cataract surgery)
- Subject satisfaction(3 months post-cataract surgery)
- Uncorrected binocular and monocular visual acuity at all distances(3 months post-cataract surgery)
- Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target(3 months post-cataract surgery)
- Contrast sensitivity (binocular)(3 months post-cataract surgery)