JPRN-jRCT2032200147已完成3 期
Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20
Bissen-Miyajima Hiroko0 个研究点目标入组 32 人开始时间: 2020年10月12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
- 32
研究概览
简要总结
The primary endpoint of this study was the percentage of eyes with <=0.25 D cylinder power at 1-2 months postoperative. The percentage of eyes with <=0.25 D of absolute refractive cylinder was 90.2% at Visit 3/3A (Day 30-60), showing a significant difference from the historical threshold calculated based on the past studies using non-toric IOLs. No AEs related to the study device were reported. No subjects discontinued the study due to AEs, and there were no safety concerns of the study device.
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
- •Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye as determined by a new Alcon Toric calculator.
- •- Planned postoperative emmetropia (spherical equivalent +-0.50 D).
- •- Other protocol-specified inclusion criteria may apply.
排除标准
- •- Irregular corneal astigmatism.
- •- History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology.
- •- Glaucoma; ocular hypertension; diabetic retinopathy; any optic nerve pathology.
- •- History of previous intraocular or corneal (refractive or trauma related) surgery.
- •- Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and LASIK.
- •- Other protocol-defined exclusion criteria may apply.
研究者
相似试验
已完成
不适用
Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular LensCorneal AstigmatismAphakiaNCT04542525Alcon Research32
已完成
不适用
Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9CataractsAstigmatismNCT01601665Alcon Research477
已完成
不适用
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian PopulationCorneal AstigmatismAphakiaNCT04528069Alcon Research58
已完成
不适用
Assessment of an intraocular lens to provide independence from optical aids at all distances following cataract surgery in patients with astigmatism.CataractACTRN12619001109190Alcon Laboratories12
已完成
不适用
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00CataractNCT02529488Alcon Research167