NCT06190925已完成不适用
Clinical Results of Asqelio Trifocal Toric Diffractive Intraocular Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Refraction
研究概览
简要总结
The goal of this observational prospective clinical study is to learn about the clinical outcomes three months after binocular implantation of Asqelio Trifocal Toric IOL in 30 patients submitted to cataract surgery following standard clinical practice. The main questions it aims to answer are: How rotationally stable is the lens after implantation and how effective is in the correction of refractive astigmatism.
Additionally, the visual performance at different distances will be assessed, as well as the patient-reported outcomes.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients submitted to cataract surgery with phacoemulsification with bilateral implantation of Asqelio Trifocal Toric IOL to avoid residual astigmatism
- •Patient signing informed consent
- •Clear intraocular media, except for cataracts in both eyes prior to surgery
- •Monocular potential postoperative visual acuity of 20/25 or better
排除标准
- •Corneal astigmatism lower than 0.75D
- •Patients who do not provide informed consent
- •Patients who do not understand the study procedure
- •Previous corneal surgery or trauma
- •Irregular cornea (e.g. keratoconus)
- •Choroidal hemorrhage
- •Microphtalmos
- •Severe corneal dystrophy
- •Uncontrolled or medically controlled glaucoma
- •Clinically significant macular changes
- •Concomitant severe eye disease
- •Non-age-related cataract
- •Severe optic nerve atrophy
- •Diabetic retinopathy
- •Proliferative diabetic retinopathy
- •Amblyopia
- •Extremely shallow anterior camera
- •Severe chronic uveítis
- •Pregnant or nursing
- •Mature/dense cataract that makes it difficult to examine the fundus preoperatively.
- •Previous retinal detachment
- •Concurrent participation in other research with drugs or clinical devices
- •Expect to require another eye surgery during the study period
结局指标
主要结局
Refraction
时间窗: 3 months after implantation
Manifest residual refraction after implantation of IOL using subjective refraction methods (D)
次要结局
- Corrected Visual acuity at intermediate distance(3 months after implantation)
- Corrected Visual acuity at near distance(3 months after implantation)
- Binocular defocus curve(3 months after implantation)
- Corrected Visual acuity at distance(3 months after implantation)
- Uncorrected Visual acuity at distance(3 months after implantation)
- Uncorrected Visual acuity at intermediate distance(3 months after implantation)
- Contrast sensitivity function(3 months after implantation)
- Patient reported outcomes - Satisfaction(3 months after implantation)
- Patient reported outcomes - Visual Symptoms(3 months after implantation)
- Uncorrected Visual acuity at near distance(3 months after implantation)
- Rotational stability(3 months after implantation)
研究者
研究点 (1)
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