Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Uncorrected Monocular Visual acuity for distance
研究概览
简要总结
The goal of this observational study is to assess the clinical outcomes of binocular implantation of Asqelio EDOF Toric IOLs in healthy cataract patients. The main questions it aims to answer are:
- What is the visual performance at different distances 3 months after implantation of Asqelio EDOF Toric in both eyes?
- What is the amount of residual refractive error following the implantation?
- What is the contrast sensitivity of patients 3 months after implantation of Asqelio EDOF Toric in both eyes?
- What is the optical quality of the eye implanted with Asqelio EDOF Toric IOL?
- What is the incidence and severity of visual symptoms after implantation of Asqelio EDOF Toric?
- What is the level of patient satisfaction after implantation of Asqelio EDOF Toric?
For this purpose, participants will be submitted to a comprehensive visual and refractive assessment, following common clinical practice, 3 months after binocular implantation of Asqelio EDOF Toric IOLs, and asked to complete visual symptoms and patient satisfaction questionnaires.
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 50 years old or more submitted to bilateral cataract surgery and implanted with Asqelio EDOF toric IOL, with cylinder value of 0.0 D.
- •Patients signing informed consent
- •Transparent media except for the cataracts
- •Potential postoperatoria visual acuity of 20/25 or better
排除标准
- •Preoperative corneal astigmatism greater than 1.00D
- •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
Uncorrected Monocular Visual acuity for distance
时间窗: 3 months after implantation
Visual acuity without additional correction determined at a distance of 4 m in LogMAR units
Uncorrected Monocular Visual acuity for near distance
时间窗: 3 months after implantation
Visual acuity without additional correction determined at a distance of 40 cm in LogMAR units
Corrected Monocular Visual acuity for near distance
时间窗: 3 months after implantation
Visual acuity with best correction determined at a distance of 40 cm in LogMAR units
Uncorrected Monocular Visual acuity for intermediate distance
时间窗: 3 months after implantation
Visual acuity without additional correction determined at a distance of 67 cm in LogMAR units
Corrected Monocular Visual acuity for distance
时间窗: 3 months after implantation
Visual acuity with best correction determined at a distance of 4 m in LogMAR units
Corrected Monocular Visual acuity for intermediate distance
时间窗: 3 months after implantation
Visual acuity with best correction determined at a distance of 67 cm in LogMAR units
Refractive error
时间窗: 3 months after implantation
Residual refractive error after implantation obtained by subjective refraction methods
次要结局
- Contrast sensitivity function under mesopic conditions(3 months after implantation)
- Aberrometry(3 months after implantation)
- Contrast sensitivity function under photopic conditions(3 months after implantation)
- Contrast sensitivity function under photopic conditions with glare(3 months after implantation)
- Contrast sensitivity function under mesopic conditions with glare(3 months after implantation)
- Binocular defocus curve(3 months after implantation)
- Patient-reported visual symptoms(3 months after implantation)
- Light distortion(3 months after implantation)
- Incidence of Adverse events(3 months after surgery)
- Patient-reported satisfaction(3 months after surgery)