Randomized Clinical Trial to Evaluate the Visual Function of Enhanced Monofocal and Extended Depth of Field Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Visual acuity at different distances
研究概览
简要总结
Randomized clinical trial to evaluate the visual performance of enhanced monofocal and extended depth-of-field intraocular lenses
详细描述
Primary Objective
To evaluate whether the implantation of enhanced monofocal intraocular lenses during cataract surgery results in fewer adverse visual phenomena (dysphotopsias) than the implantation of extended depth-of-field (EDoF) intraocular lenses.
Secondary Objectives
To evaluate whether there are differences in best-corrected visual acuity at various distances, contrast sensitivity, visual quality, and quality of life between patients implanted with enhanced monofocal intraocular lenses and those implanted with extended depth-of-field intraocular lenses.
To evaluate whether there are differences in best-corrected visual acuity at various distances, contrast sensitivity, visual quality, and quality of life among the four enhanced monofocal intraocular lenses analyzed in the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bilateral cataracts at different stages of development.
- •Patients with functional visual demands.
- •Age between 45 and 80 years.
- •Male or female sex.
- •Ability to provide informed consent.
排除标准
- •Preoperative Exclusion Criteria
- •Medical criteria:
- •Corneal astigmatism greater than 1.0 diopter. Pre-existing ocular pathology. Previous refractive surgery. Previous corneal or intraocular implant. Poor general health status or potentially reduced neuroadaptation capacity due to previous stroke, Alzheimer's disease, other forms of dementia, etc.
- •Unrealistic postoperative visual expectations.
- •Intraoperative Withdrawal Criteria
- •Vitreous loss.
- •Pupillary trauma.
- •Factors likely to affect the medium-term performance of the intraocular lens: Zonular damage, Capsulorhexis tear or injury, Capsular rupture, Endothelial damage.
结局指标
主要结局
Visual acuity at different distances
时间窗: 1 month, 3 months, 6 months
Far vision, intermediate vision, near vision
Dysphotopsias
时间窗: 1 month, 3 months, 6 months
Dysphotopsias after the IOL implantation
次要结局
未报告次要终点