Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Monocular corrected distance visual acuity (CDVA)
研究概览
简要总结
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens.
The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.
The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 640AD IOLs mono- or binocularly between December 2021 - December 2022.
Data from five visits will be collected:
- Baseline preoperative (maximum 30 days prior to surgery)- retrospective
- IOL implantation Day 0 - retrospective
- Postoperative visit at Day 1 (+/- 0 days) - retrospective
- Postoperative visit at 1 month (+/- 2 weeks) - retrospective
- Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males or females above 18 years of age;
- •Pseudophakic patients implanted with 640AD monofocal IOLs (implanted between December 2021 - December 2022);
- •Diagnosis of cataract and/or ametropia (hyperopia, myopia);
- •Subject who has signed an informed consent form.
- •Patients who have participated in all visits that are subject to retrospective data collection.
排除标准
- •Patients who are not targeted to emmetropia ( outside -0,5 and 0,5 D)
- •Patients with the following condition(s) at the time of the baseline visit:
- •Corneal astigmatism > 1.5 D
- •Uncontrolled diabetic retinopathy
- •Iris neovascularization
- •Congenital eye abnormality
- •Uncontrolled glaucoma
- •Pseudoexfoliation syndrome
- •Amblyopia
- •AMD (advanced AMD)
- •Retinal detachment
- •Prior ocular surgery in personal medical history
- •Previous laser treatment
- •Corneal diseases
- •Severe retinal diseases (dystrophy, degeneration)
- •High myopia
- •Inadequate visualization of the fundus on preoperative examination
- •Patients deemed by the clinical investigator because of any systemic disease
- •Pregnancy
- •Eye trauma in medical history
- •Current use of systemic steroids or topical ocular medication
- •Patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.)
结局指标
主要结局
Monocular corrected distance visual acuity (CDVA)
时间窗: 12 months postoperatively
To compare monocular corrected distance visual acuity (CDVA) between 12 months postoperative and preoperative results.
次要结局
- Monocular uncorrected distance visual acuity (UDVA)(12 months postoperatively)
- UDVA and CDVA(12 months postoperatively)
- Manifest residual refraction(12 months postoperatively)
- Patient satisfaction(12 months postoperatively)