Combining a Monofocal With an EDOF IOL: Is There an Improvement in Quality of Vision After Cataract Surgery Over Bilateral Monofocal IOL Implantation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.
研究概览
简要总结
The goal of this clinical trial is to compare visual quality after cataract surgery between two groups: bilateral monofocal intraocular lenses (IOL) and monofocal and contralateral extended depth-of-focus (EDOF) IOL implantation. The main question it aims to answer is:
• does the combination of both monofocal and EDOF IOLs presents an advantage over bilateral monofocal IOL implantation in the daily life of patients undergoing cataract surgery without the disadvantages of bilateral EDOF IOL implantation?
Participants will:
- be randomised in either bilateral monofocal group or monofocal and EDOF group
- undergo visual acuity testing with and without correction at all distances
- be asked to complete a quality of vision questionnaire
- undergo non-invasive examinations to measure residual astigmatism, contrast sensitivity, straylight, optical aberrations, reading spead.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 50 and 90 years with bilateral cataract without concomitant
排除标准
- •Exclusion Criteria:
- •prior refractive surgery
- •patients with corneal opacities, retinopathy, opticopathy, glaucoma, uveitis and amblyopia
- •patients with corneal astigmatism greater than 3 diopters (D)
- •patients with expected postoperative astigmatism higher than 0.50D
- •prior ocular surgery in the last six months
- •patients with prior unilateral cataract surgery
结局指标
主要结局
Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.
时间窗: 3 months
Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.
次要结局
未报告次要终点
研究者
Karolien Termote, MD FEBOpht
Clinical Staff Member Ophthalmology
Vrije Universiteit Brussel