NCT02903927已完成不适用
Prospective Comparative Randomized Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- Uncorrected distance visual acuity (UCVA) (monocular)
研究概览
简要总结
The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601 PY for the monocular uncorrected distance visual acuity and compare it to the reference monofocal IOL Acrysof IQ SN60WF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
- •Patients of any gender, aged 50 to 90 years;
- •Senile cataract in at least 1 eye;
- •Assured follow-up examinations;
- •Healthy eyes besides clinically significant cataract
- •Biometry measurement/cataract density compatible with the IOLMaster evaluation.
- •Post-operative inclusion criteria:
- •IOL implanted in the capsular bag;
- •The IOL model (CT LUCIA 601PY or Acrysof IQ SN60WF) has been implanted;
- •No intraoperative complications; no damaged capsular bag, no intraocular hemorrhage; no can opener rhexis.
排除标准
- •• Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial;
- •Patients whose freedom is impaired by administrative or legal order;
- •Current participation in another drug or device investigation;
- •Allergy to heparin
- •Monophthalmic patient
- •Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse the operated eye
- •Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
- •Diabetic retinopathy
- •Traumatic cataract
- •Microphthalmus
- •Amblyopia
- •Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
- •Patient expected to require retinal laser treatment before the end of the follow-up
- •Previous intraocular and corneal surgery
- •Expected postop. astigmatism greater than 1 D
- •Any type of corneal disorder
- •Diabetes mellitus
- •Pseudoexfoliation syndrome (PXF)
- •Glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
- •Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
研究组 & 干预措施
CT LUCIA
Experimental
干预措施: Implantation of CT LUCIA IOL (Device)
Acrysof IQ Sn60WF
Active Comparator
干预措施: Implantation of Acrysof IQ SN60WF IOL (Device)
结局指标
主要结局
Uncorrected distance visual acuity (UCVA) (monocular)
时间窗: 6 months
次要结局
未报告次要终点
研究者
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