Comparison of Clinical Outcomes After Implantation of MICROPURE (PhysIOL) and PodEye (PhysIOL) Monofocal Intraocular Lenses Into the Two Eyes of the Same Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- monocular Corrected Distance Visual Acuity (CDVA)
研究概览
简要总结
Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses.
详细描述
This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in the contralateral eye of the same patient.
The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. and PODEYE
The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference is the mechanical design of the haptics, that is not expected to have an influence on the clinical outcomes.
The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
In total 76 patients will be recruited for this clinical study and receive the implantation of Micropure 1.2.3. and POPDEYE intraocular lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cataractous eyes with no comorbidity
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Clear intraocular media other than cataract;
- •Signed informed consent
排除标准
- •Age of patient < 45 years;
- •Irregular astigmatism;
- •Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°;
- •Difficulty for cooperation (distance from their home, general health condition);
- •Previous intraocular or corneal surgery;
- •Traumatic cataract;
- •Any ocular comorbidity;
- •Instability of keratometry or biometry measurements.
结局指标
主要结局
monocular Corrected Distance Visual Acuity (CDVA)
时间窗: 6 months postoperative
Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to eyes implanted with the comparator PODEYE at the 6 months follow up visit.
次要结局
- Manifested refraction(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Slitlamp examination - Signs of inflammation(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions(preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Monocular Contrast Sensitivity under photopic light conditions(6 months postoperative)
- Monocular Contrast Sensitivity under mesopic light conditions(6 months postoperative)
- Slitlamp examination - Fundus(preoperative, 12 months postoperative)
- Slitlamp examination - Pupillary block(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Slitlamp examination - Retinal detachment(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Slitlamp examination IOL tilt(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions(preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Slitlamp examination - Corneal status(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Slitlamp examination - Status of anterior and posterior capsule(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Slitlamp examination - IOL opacity(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Slitlamp examination - IOL decentration(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Slitlamp examination - IOL discoloration(preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)