Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- CDVA
研究概览
简要总结
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are 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 690AD or 690ADY IOLs mono- or binocularly between September 2021 - March 2022.
Data from five visits will be collected:
- Baseline preoperative (maximum 90 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 690AD or 690ADY monofocal IOLs (implanted between September 2021 - March 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.
- •Patients with the following condition(s) at the time of the baseline visit:
- •Corneal astigmatism > 1.0 diopter
- •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
CDVA
时间窗: 12 months postoperatively
Monocular corrected distance visual acuity (CDVA) To compare monocular corrected distance visual acuity (CDVA) between groups implanted with 690AD and 690ADY monofocal IOLs at 12 months postoperatively.
次要结局
- UDVA(12 months postoperatively)
- UDVA and CDVA(12 months postoperatively)
- Spherical Equivalent(12 months postoperatively)
- Patient satisfaction(12 months postoperatively)
- Cylinder(12 months postoperatively)
- Axis of the eye(12 months postoperatively)