NCT03172351已完成不适用
Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Defocus curve measurement
研究概览
简要总结
prospective, comparative (3 arms), randomized, multicentric clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 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 Clinical Investigational Plan and who has given his/her written informed consent;
- •Patients of any gender, aged 50 to 80 years;
- •Assured follow-up examinations;
- •clinically significant bilateral cataract;
排除标准
- •Patients unable to meet the limitations of the Clinical Investigational Plan 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;
- •Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye
- •Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
- •Pseudoexfoliations syndrome
- •Pathologic miosis or Pharmacotherapy with miotic agent
- •Keratoconus
- •Chronic or recurrent uveitis
- •Diabetic retinopathy
- •Uncontrolled glaucoma and or IOP>24mmHg
- •Choroidal hemorrhage,
- •All kind of infections (acute ocular disease, external/internal infection, systemic infection)
- •Traumatic cataract
- •Microphthalmia
- •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 4-6 months follow-up
- •Previous intraocular and corneal surgery
- •Expected postop. astigmatism greater than 1 D
- •Any type of corneal disorder
- •Systemic or ocular pharmacotherapy, which can impact the visual acuity,
- •Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion
- •Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus)
- •pregnancy or lactation period for female patients
结局指标
主要结局
Defocus curve measurement
时间窗: 1 month
次要结局
未报告次要终点
研究者
研究点 (2)
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