Clinical Trial on the Visual Function of Enhanced Monofocal and EDoF Intraocular Lenses
Randomized Clinical Trial to Evaluate the Visual Function of Enhanced Monofocal and Extended Depth of Field Intraocular Lenses
研究概览
详细说明
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.
To evaluate whether there are differences in best-corrected visual acuity at various distances, contrast sensitivity, visual quality, and quality of life between the two extended depth-of-field intraocular lenses analyzed in the present study.
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
INCLUSION CRITERIA:
- 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.
EXCLUSION CRITERIA:
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1: Implantation of the Clareon Vivity intraocular lens
EDoF IOL
|
Implantation of intraocular lens
|
|
实验性的：Group 2: Implantation of the TECNIS Eyhance intraocular lens
Enhanced monofocal IOL
|
Implantation of intraocular lens
|
|
实验性的：Group 3: Implantation of the RayOne EMV intraocular lens
Enhanced monofocal IOL
|
Implantation of intraocular lens
|
|
实验性的：Group 4: Implantation of the IsoPure Serenity intraocular lens
Enhanced monofocal IOL
|
Implantation of intraocular lens
|
|
实验性的：Group 5: Implantation of the Vivinex Impress intraocular lens
Enhanced monofocal IOL
|
Implantation of intraocular lens
|
|
实验性的：Group 6: Implantation of the TECNIS PureSee intraocular lens
EDoF IOL
|
Implantation of intraocular lens
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Visual acuity at different distances
大体时间：1 month, 3 months, 6 months
|
Far vision, intermediate vision, near vision
|
1 month, 3 months, 6 months
|
|
Dysphotopsias
大体时间：1 month, 3 months, 6 months
|
Dysphotopsias after the IOL implantation
|
1 month, 3 months, 6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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