A Prospective, Open-Label, Single-Center Study of the Safety and Effectiveness of the AVL200 Modular Intraocular Lens System.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1)Uncorrected distance visual acuity (UCDVA) – monocular and binocular.
研究概览
简要总结
This is a Prospective, single-center, open-label. After preoperative screening to determine eligibility, subjects will undergo cataract surgery in the first eye with implantation of the AVL200 IOL System and return for follow-up visits postoperatively. Implantation of the AVL200 in the fellow eye should be performed approximately 1 month after primary eye implantation. The subject will return for fellow eye follow-up visit postoperatively, then follow-up on the fellow eye will occur according to the primary eye visit schedule. The AVL200 IOL System is a modular intraocular lens (IOL) consisting of a fluid-filled, shape-changing Base and a fixed-power optic Lens. The AVL200 is intended for permanent implantation in the eye after cataract removal. The AVL200 is designed to respond to natural accommodative forces in the eye to provide a useful range of vision at near, intermediate, and distance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Visually significant cataract.
- •Best corrected distance visual acuity between 20/40 and 20/
- •Corneal astigmatism ≤ 1.5 diopters.
- •Potential distance visual acuity of 20/25 or better.
排除标准
- •Uncontrolled systemic disease that could increase operative risk or confound outcome.
- •Use of medication that could affect accommodation.
- •Previous corneal surgery or significant corneal abnormalities.
- •Ocular pathology or degenerative disorder having potential to impair visual acuity.
- •Pupil abnormality.
- •Intraoperative cataract surgery complications that could affect IOL implantation or positioning.
结局指标
主要结局
1)Uncorrected distance visual acuity (UCDVA) – monocular and binocular.
时间窗: Post-Operation Month 1,3,6,12 and 36.
2)Uncorrected intermediate visual acuity (UCIVA) – monocular and binocular.
时间窗: Post-Operation Month 1,3,6,12 and 36.
3) Uncorrected distance visual acuity (UCDVA) – monocular and binocular.
时间窗: Post-Operation Month 1,3,6,12 and 36.
4)Distance-corrected intermediate visual acuity (DCIVA) – monocular and binocular.
时间窗: Post-Operation Month 1,3,6,12 and 36.
5)Distance-corrected near visual acuity (DCNVA) – monocular and binocular.
时间窗: Post-Operation Month 1,3,6,12 and 36.
次要结局
- 1)Ocular adverse events (AE)(2)Secondary surgical interventions related to design characteristics of the AVL200 IOL System)