Safety and Efficacy of the Bi-Aspheric Monofocal Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Defocus curve
研究概览
简要总结
This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination.
详细描述
This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a single visit in the facilities of Chang Gung University Hospital at least 3 months after the surgery. Patients will undergo a routine basic ophthalmological examination.
Additionally, and retrospectively, the patients' medical records will be reviewed to obtain information on visual acuity and adverse events at postoperative visit carried out 1 month after surgery.
The data corresponding to the preoperative values of corneal curvature (flat meridian, curved meridian and axes), axial length measured by biometry, visual acuity and those corresponding to the implanted IOL will also be collected from the medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Subjects 18 years of age or older who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye
- •Willingness to cooperate with and complete all post-operative visits
- •Ability to comprehend and sign an informed consent
排除标准
- •Any pathology that could reduce Visual Acuity (VA) (including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely narrow anterior chamber depth, microphthalmos, clinically significant macular/RPE changes, retinal detachment, corneal transplant, chronic sever uveitis, choroidal hemorrhage, recurrent severe inflammation of the anterior or posterior segment of unknown etiology, iris neovascularization, medically controlled or uncontrolled glaucoma, clinically significant macular degeneration, or diagnosis of pseudoexfoliation).
- •Previous ocular surgery (including YAG-laser) or trauma
- •Clinically significant irregular astigmatism
- •Concomitant severe eye disease
- •Pregnant or lactating
- •Any other ocular or systemic condition which, in the opinion of the investigator, should exclude the subject from the study
- •Concurrent participation in another drug or device investigation
- •May be expected to require other ocular surgery during the study
研究组 & 干预措施
aspicio Monofocal IOL
A bi-aspheric monofocal IOL is implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery
干预措施: aspicio Monofocal IOL (Device)
结局指标
主要结局
Defocus curve
时间窗: 3 months after implantation
Photopic monocular defocus curve, -4.0 D \~ +2.0 D
CDVA
时间窗: 3 months after implantation
Photopic monocular best corrected distance visual acuity (CDVA), 400cm
次要结局
- CIVA(3 months after implantation)
- Satisfaction questionnaire(3 months after implantation)
- UIVA(3 months after implantation)
- AE(3 months after implantation)
- UDVA(3 months after implantation)
- IOL glistening(3 months after implantation)
- PCO(3 months after implantation)