Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens
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
- Residual refraction
研究概览
简要总结
The goal of this observational study is to evaluate whether the Asqelio™ Trifocal intraocular lens (IOL) can improve refractive outcomes and optical quality in patients (aged ≥45 years) undergoing cataract surgery or clear lens exchange, including both male and female participants. The main questions it aims to answer are:
- Does the Asqelio™ Trifocal IOL provide accurate refractive correction with minimal residual refractive error?
- Does the lens reduce light distortion and provide good visual acuity at multiple distances (far, intermediate, near)?
Researchers will not use a comparison group, as this is a post-marketing, single-arm observational study.
Participants will undergo bilateral implantation of the Asqelio™ Trifocal IOL during cataract or lens replacement surgery and attend a study follow-up exam approximately 270±90 days post-surgery.
Complete evaluations including:
- Manifest refraction testing
- Uncorrected and corrected visual acuity at far, intermediate, and near distances
- Binocular defocus curve analysis
- Contrast sensitivity testing
- Light distortion analysis using a Light Distortion Analyzer
- Patient-reported outcomes via the Catquest-9SF and visual symptoms questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Patients 50 years of age or older undergoing cataract surgery by phacoemulsification and binocular IOL implant AsqelioTM Trifocal TFLIO130C
- •Independence of use of glasses after surgery.
- •IOL power between +5.0D and +34.0D
- •Transparent intraocular media except for cataracts in both eyes.
- •Potential postoperative visual acuity of 20/25 or better.
排除标准
- •Preoperative corneal astigmatism greater than 1.0D
- •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 uveitis
- •Pregnant or nursing
- •Mature/dense cataract that makes it difficult to examine the eye fundus preoperatively.
- •Previous retinal detachment
- •Concurrent participation in other research with drugs or clinical devices
结局指标
主要结局
Residual refraction
时间窗: 270±90 days after surgery
Residual refractive error determined by subjective refraction procedures and expressed in diopters of spherical and cylindrical power
Light Distortion Index
时间窗: 270±90 days from surgery
The distortion index is calculated as the ratio of the area of points missed by the subject and the total area explored using the Light Distortion Analyzer, and is expressed as a percentage
次要结局
- Visual acuity(270±90 days after surgery)
- Binocular defocus curve(270±90 days after surgery)
- Contrast sensitivity(270±90 days after surgery)
- Patient-Reported Outcomes - CATQuest9SF(270±90 days after surgery)
- Patient-Reported Outcomes - Visual symptoms(270±90 days after surgery)