NCT01268540已完成不适用
Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 6
- 主要终点
- percent reduction of absolute cylinder
研究概览
简要总结
The purpose of this multi-center clinical trial is to determine the safety and efficacy of the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive astigmatism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
- •Have at least one eye that meets the ranges of pre-operative corneal cylinder as specified by this study's guidelines, i.e. corneal cylinder of at least 1.0 D (after accounting for changes in corneal cylinder due to the incision)
- •Have potential Best Corrected Visual Acuity of 20/30 or better after implantation of a study lens
- •Have clear intraocular media other than cataract
- •Have preoperative Best Corrected Visual Acuity equal to 20/40 or worse, with or without a glare source
排除标准
- •Have atonic pupils or physiologically small pupils in either eye (unable to dilate to at least 4 mm)
- •Have irregular astigmatism in the operative eye, or refractive cylinder resulting only from lenticular astigmatism in the operative eye
- •Have corneal pathology potentially affecting corneal topography, or other corneal abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
- •Have undergone previous refractive corneal surgery in the operative eye
- •Have been diagnosed with any degenerative retinal disorders (e.g. soft drusen, macular degeneration or other progressive retinal disorders) in the operative eye that are predicted to cause future visual acuity losses to a level of 20/30 or worse during the postoperative follow-up time requirements of this study
- •Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
研究组 & 干预措施
NHT15
Experimental
Aspheric Toric Intraocular Lens Models NHT15
干预措施: NHT15, NHT30, & NHT53 (Device)
FY-60AD
Active Comparator
Aspheric Non-toric Intraocular Lens: Model FY-60AD
干预措施: FY-60AD (Device)
NHT30
Experimental
Aspheric Toric Intraocular Lens Model NHT30
干预措施: NHT15, NHT30, & NHT53 (Device)
NHT53
Experimental
Aspheric Toric Intraocular Lens Models NHT53
干预措施: NHT15, NHT30, & NHT53 (Device)
结局指标
主要结局
percent reduction of absolute cylinder
时间窗: up to 14 months
次要结局
- Lens rotation or misalignment and patient satisfaction(up to 14 months)
研究者
研究点 (6)
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