NCT04907500已完成不适用
Prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens
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
- 387
- 试验地点
- 1
- 主要终点
- Monocular corrected distance visual acuity (CDVA)
研究概览
简要总结
Evaluation of the clinical safety and effectiveness of an hydrophilic acrylic intraocular lens
详细描述
To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) and the distance-corrected near visual acuity (DCNVA) at 6 months postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients of any gender, aged 18 years or older
- •Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye
- •Patient is willing and capable of providing informed consent
- •Patient is willing and capable of complying with visits and procedures as defined by this protocol
排除标准
- •Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
- •Endothelial cell count of less than 2000/mm2
- •Ocular disorder that could potentially cause a clinically significant future visual acuity loss
- •Preoperative corneal astigmatism ative corneal to be < 1 D.
- •Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
- •Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
- •Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
- •Any History of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis
- •Any acute infection (acute ocular disease, external/internal infection, systemic infection)
- •Any previous intraocular and corneal surgery
- •Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
- •Current systemic or ocular pharmacotherapy that effects patients'vision
- •Current pathology or condition that could be a risk for the patient according to the investigator opinion
- •Women during pregnancy and/or lactation
- •Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
- •Patients whose freedom is impaired by administrative or legal order
- •Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients'vision
研究组 & 干预措施
Multifocal IOL
Experimental
Implantation of a multifocal intraocular lens
干预措施: Intraocular lens (Device)
结局指标
主要结局
Monocular corrected distance visual acuity (CDVA)
时间窗: 6 months after the implantation
Monocular corrected distance visual acuity measured in logMAR
次要结局
未报告次要终点
研究者
研究点 (1)
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