Presbyopic Phakic Intraocular Lens for Myopia Correction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Uncorrected Distance Visual Acuity (UDVA)
研究概览
简要总结
This is a prospective single-center study of implantations of the presbyopic version of phakic intraocular lens IPCL (EyeolUK, United Kingdom).
详细描述
Participants are impanted with the phakic intraocular lens IPCL (EyeolUK, United Kingdom) and monitored during 2 years period. Visual acuity for near and distance is evaluated, along with refraction and endothelium cell density.
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
- 38 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CDVA < 0.3 LogMAR
- •Presbyopia with moderate to high myopia
排除标准
- •Corneal endotehleial cell density below 2000 cells/mm2
- •Corneal dystrophies
- •ACD less than 2.8 mm
- •history or current uveitis
- •acute ocular inflammation
- •chronic uveitis
- •previous intraocular or refractive surgery
- •preexisting ocular pathologic which may affect postoperative results
研究组 & 干预措施
Implantation phakic intraocular lens
Presbyopic posterior chamber phakic intraocular lens IPCL implanted to the participants eye
干预措施: Presbyopic posterior chamber phakic intraocular lens IPCL (Device)
结局指标
主要结局
Change in Uncorrected Distance Visual Acuity (UDVA)
时间窗: 2 years
Distance visual acuity tested without any correction
Change in Uncorrected Near Visual Acuity (UNVA)
时间窗: 2 years
Near visual acuity tested without any correction
次要结局
- Change in near refraction(2 years)
- Change in Corrected Near Visual Acuity (CNVA)(2 years)
- Change in distance refraction(2 years)
- Change in Corrected Distance Visual Acuity (CDVA)(2 years)