NCT04789538已完成不适用
Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens (509)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens
详细描述
To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) at 12-24 month postoperative.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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 at the time of the surgery
- •Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery
- •Currently implanted with the study device into the capsular bag in at least one eye
- •One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit
- •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) or CDVA not available preoperatively
- •Preoperative documented endothelial cell count of less than 2000/mm2 (if available)
- •Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss
- •Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
- •Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
- •Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
- •Any preoperative documented 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 preoperative acute infection (acute ocular disease, external/internal infection, systemic infection)
- •Any previous preoperative intraocular and corneal surgery
- •Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
- •Preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision
- •Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion
- •Women during pregnancy and/or lactation at time of enrollment into the study
- •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
- •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
结局指标
主要结局
Visual acuity
时间窗: 12 to 24 months after the implantation
Visual acuity at far distance
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Evaluation of a Spherical Hydrophilic Acrylic Intraocular LensCataract SenileNCT04998409Carl Zeiss Meditec AG242
已完成
不适用
Evaluation of an Hydrophilic Acrylic Intraocular LensCataract SenileNCT04793789Carl Zeiss Meditec AG249
已完成
不适用
Evaluation of a Trifocal LensCataract SenileNCT04545671Carl Zeiss Meditec AG389
已完成
不适用
Prospective Evaluation of an Hydrophilic Acrylic Intraocular LensCataract SenileNCT04907500Carl Zeiss Meditec AG387
撤回
不适用
Hydrophilic Acrylic Intraocular LensCataract ExtractionNCT00708331EyeKon Medical, Inc.