NCT06578884Enrolling By Invitation不适用
A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
Medicontur Medical Engineering Ltd1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary Performance Endpoint - CDVA
研究概览
简要总结
Medicontur preloaded hydrophobic monofocal toric intraocular lenses (IOLs) are indicated to improve vision at far distance in adults with or without cataract and correction of pre-existing corneal astigmatism 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 investigation will be performed as a prospective, non-comparative, single arm study with a single center design. Patients will be enrolled who are assigned to be implanted with the 877PTY IOLs mono- or binocularly between January 2024 - June 2025.
Data from six visits will be collected:
- Visit 1: Screening and Baseline (up to 90 days prior to the surgery)
- Visit 2: IOL implantation (Day 0)
- Visit 3: Day 1 post-operatively (+/- 0 day)
- Visit 4: Day 7 post-operatively (+/- 3 days)
- Visit 5: Month 1 post-operatively (+/- 2 weeks)
- Visit 6: Month 6 post-operatively (+/- 1 month)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 patients (18 years old and older);
- •cataract and/or corneal astigmatism diagnosis;
- •indication for cataract surgery or refractive lens exchange;
- •recommended cylinder correction with toric IOL with cylinder power ≥1.0D;
- •clear intraocular media other than cataract;
- •signed informed consent form;
排除标准
- •irregular astigmatism;
- •patients who are not targeted to emmetropia (predicted residual spherical equivalent and/or astigmatism is out of the range of ±0.5D and ±0.38D respectively);
- •any retinopathy or maculopathy that affects the vision;
- •iris neovascularization;
- •congenital eye abnormality affecting visual performance;
- •advanced glaucoma;
- •pseudoexfoliation syndrome affecting IOL stability;
- •amblyopia;
- •retinal detachment;
- •prior ocular surgery in personal medical history;
- •irregular corneal curvature or corneal diseases affecting visual performance;
- •high myopia (axial length ≥ 26,5 mm);
- •inadequate visualization of the fundus on preoperative examination;
- •dilated pupil size not large enough to visualize toric IOL axis markings postoperatively based on the Investigator's decision;
- •eye trauma in medical history;
- •instability of keratometry or biometry measurements;
- •prior corneal refractive surgery such as LASIK, PRK, or SMILE;
- •patients deemed ineligible by the investigator because of any systemic disease or treatment;
- •pregnancy or lactation;
- •current use of systemic steroids or external ophthalmic drugs;
- •concurrent participation in another drug or device investigation.
- •Intraoperative exclusions: the presence of the following intraoperative exclusion criteria will lead to the exclusion of the subject:
- •Any unexpected or serious intraoperative complication that makes IOL implantation impossible or results in implantation of another type of IOL that is outside the scope of this clinical trial.
结局指标
主要结局
Primary Performance Endpoint - CDVA
时间窗: 6 months postoperatively
Visual acuity: monocular CDVA at 6 months after IOL implantation
次要结局
- Secondary Performance Endpoint - UDVA(6 months postoperatively)
- Secondary Performance Endpoint - Subjective CYL(6 months postoperatively)
- Secondary Performance Endpoint - Residual CYL and SEQ(6 months postoperatively)
- Secondary Performance Endpoint - Rotational stability(6 months postoperatively)
- Secondary Performance Endpoint - Injector handling(6 months postoperatively)
- Secondary Performance Endpoint - Patient satisfaction (VFQ-25)(6 months postoperatively)
- Secondary Performance Endpoint - Glistening(6 months postoperatively)
研究者
研究点 (1)
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