JPRN-jRCT2072200052已完成3 期
Clinical Investigation of the Multifocal IOL POD F GF in Cataracteous Eyes
Maeda Naoyuki0 个研究点目标入组 23 人开始时间: 2020年11月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
研究概览
简要总结
Visual acuity at 120-180 days postoperatively was demonstrated to be noninferior to that of the approved monofocal IOL for distance-corrected visual acuity (5 m) and superior for distance-corrected intermediate visual acuity (80 cm) and distance-corrected near visual acuity (40 cm). No AEs related to the study device were reported. Based on the efficacy and safety results shown in this clinical trial, this investigational lens is considered clinically useful.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Subject with preoperative astigmatism < 1.0 D
- •- The subject must be able to undergo second eye surgery within 30 days of the first eye surgery.
- •- Other protocol-specified inclusion criteria may apply.
排除标准
- •- Irregular corneal aberration that affects postoperative visual function as demonstrated by corneal topography;
- •- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.5 decimal for CDVA;
- •- Subjects who may be expected to require ocular surgery (other than blepharo-surgery, laser surgery of fundus and YAG capsulotomy) during the study;
- •- Previous refractive surgery;
- •- Other protocol-defined exclusion criteria may apply.
研究者
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