Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Rotational stability of the implant
研究概览
简要总结
The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation.
Information will be obtained from patients operated by routine clinical practice with toric monofocal ASQELIO IOL in at least one eye. After confirmation of inclusion, the preoperative examination will be performed, and after surgery an evaluation will be performed the following day, one week, one month and three months after surgery.
详细描述
In cataract surgery, the opacified lens is removed by phacoemulsification and replaced by an artificial IOL.The most common risk of cataract surgery is the development of a condition called posterior capsular opacification (PCO) that causes further deterioration of visual function. Toric intraocular lenses correct corneal astigmatism and avoid residual refractive errors in these subjects. For their efficacy in this refractive error correction, it is essential that, once implanted, these lenses are rotationally stable.The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens during the first 3 months after implantation.
All patients participating in the study are candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation model TLIO130 from AST Products, Inc., with CE marking.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with LIO ASQELIO.
- •Subjects for whom postoperative emmetropia was planned (±0.5 D spherical equivalent)
排除标准
- •Preoperative corneal astigmatism less 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).
- •Microphthalmos.
- •Severe corneal dystrophy.
- •Pregnant or breastfeeding'.
- •Mature/dense cataract making eye bottom preoperative examination difficult.
- •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
Rotational stability of the implant
时间窗: During 3 months after IOL implantation
Evaluated at each visit by analysis of slit-lamp backlight images, following the method described by Wolffsohn and Buckhurst. By means of backlighting, the IOL markings indicating the axis in which the astigmatic power is located will be observed and by image analysis it will be determined and quantified whether the lens has been rotated.
Visual acuity
时间窗: During 3 months after IOL implantation
Best corrected distance visual acuity in LogMAR units using the ETDRS chart
次要结局
- Satisfaction and quality of vision questionnaire(During 3 months after IOL implantation)
- Adverse events(During 3 months after IOL implantation)
- Refraction(During 3 months after IOL implantation)