A Prospective, Multi-center, Single-phase, Non-randomized, Open-label Study to Assess the Safety and Efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) for the Correction of Aphakia Following Phacoemulsification Cataract Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 2
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) when implanted in the posterior chamber of the human eye for the optical correction of aphakia following cataract extraction.
详细描述
A prospective, single-phase, non-randomized, open-label study to include patients with operable cataract of the human crystalline lens who have a potential post-operative best corrected visual acuity of 20/40 or better and no pre-existing progressive sight-threatening ocular disorders. Patients who are eligible per inclusion / exclusion criteria will undergo phacoemulsification cataract extraction and then implantation of the Hoya HMY Model YA-60BB posterior chamber intraocular lens. Each patient will be followed-up at specific time intervals to assess safety and effectiveness, for up to 36 months.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with cataract who are eligible for phacoemulsification cataract extraction of the lens through an incision of approximately 4 mm, and primary implantation of a posterior chamber intraocular lens.
- •Patients must have no pre-existing ocular conditions that preclude the ability of the treated eye to achieve BCVA of 20/40 or better after IOL implantation.
- •Patients must be at least 21 years of age.
- •Patients must sign a written informed consent form.
- •Patients must be able and willing to return for scheduled follow-up examinations after surgery throughout the 36 month study.
排除标准
- •Patients with a history of/or clinical signs of any of the following sight-threatening conditions:
- •Previous Retinal Detachment or retinal pathology in operative eye, only
- •Macular Degeneration in either eye
- •Macular Edema in either eye
- •Persistent Iritis/Uveitis in operative eye, only
- •Uncontrolled Glaucoma or under current treatment for glaucoma in either eye
- •Significant Corneal Disease in operative eye, only
- •Proliferative Diabetic Retinopathy in either eye
- •Patients who have had previous ocular surgery, of any kind, within the last 6 months or patients who have had previous ocular surgery at any time and who do not have potential BCVA after cataract extraction/IOL implantation of 20/40 or better
- •Patients who have best corrected vision worse than 20/200 in the fellow eye.
- •Patients with serious (i.e., life threatening) non-ophthalmic disease which may preclude study completion.
- •Patients who have undergone previous cataract extraction and intraocular lens implantation.
- •Patients unwilling or unable to sign the IRB-approved informed consent document for the study or who cannot or will not complete the study's examination schedule.
- •Patients who are currently enrolled in another clinical trial, or who exited a clinical trial within the last 30 days.
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: 12 months postoperative
次要结局
- Adverse events/complications(12 months postoperative)