jRCT2042250219招募中不适用
A Multicenter, Single-Arm, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of the Toric Intraocular Lens N3T in Cataract Patients with Corneal Astigmatism
未提供0 个研究点目标入组 65 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 40age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Patients with an age of >=40 years when signed and dated informed consent.
- •(2) Patients with age-related cataract in one or both eyes.
- •(3) Patients with a pupil diameter of >=5 mm in the study eye under mydriasis.
- •(4) Patients whose calculated lens power for the study eye is within the range of the investigational device's equivalent spherical power and cylindrical refractive power.
- •(5) Patients whose predicted postoperative astigmatism in the study eye is <0.5 D.
- •(6) Patients whose postoperative uncorrected visual acuity with spherical addition in the study eye is expected to be >=0.
- •(7) Patients who are willing to undergo the required postoperative examinations and able to complete all visits throughout the study period.
- •(8) Patients who understand the informed consent document and are able to provide written informed consent.
- •If both eyes meet the inclusion criteria, both eyes may be included in the study. However, for patient safety, surgery on the fellow eye should be performed at least 1-2 weeks after the postoperative examination of the first operated eye.
排除标准
- •(1) Patients with the following diseases in the study eye:
- •Irregular corneal astigmatism
- •Corneal abnormalities such as stromal, epithelial, or endothelial dystrophies
- •Corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
- •Corneal disorders (e.g., corneal opacity, pterygium, superficial punctate keratitis)
- •Degenerative retinal disorders in which retinal findings indicate a postoperative visual prognosis of <0.6 decimal visual acuity (e.g., macular degeneration, retinal degeneration, other retinal disorders)
- •Diabetic retinopathy
- •Abnormalities associated with an increased risk of zonular rupture (e.g., zonular weakness, capsular abnormalities, pseudoexfoliation syndrome)
- •Markedly shallow anterior chamber
- •Microphthalmos
- •Long axial length (>=28 mm)
- •Active inflammation in the anterior or posterior segment
- •Uncontrolled ocular hypertension or glaucoma
- •Optic nerve atrophy
- •Congenital ocular abnormalities
- •Poor mydriasis
- •Severe dry eye or other ocular surface abnormalities
- •Systemic diseases affecting the eye (e.g., atopic disease)
- •(2) Patients who require or have previously undergone corneal transplantation in the study eye.
- •(3) Patients with a history of corneal refractive surgery in the study eye.
- •(4) Patients for whom a secondary surgical procedure in the study eye is reasonably expected during the study period (except for YAG laser posterior capsulotomy, which is permitted).
- •(5) Patients who are participating in another clinical trial of a drug or medical device at the time of informed consent, or who are expected to participate in another clinical trial during this study.
- •(6) Patients with cognitive impairment or psychiatric disorders that may interfere with accurate examinations or measurements.
- •(7) Pregnant or lactating women; women who are pregnant or who may become pregnant (e.g., positive pregnancy test); or women who intend to become pregnant or who cannot use appropriate contraception during the study period.
- •(8) Any other patients deemed unsuitable for participation by the principal investigator or sub-investigator.
研究者
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