NCT01098812已完成3 期
Clinical Evaluation of the TECNIS® Toric 1-Piece Intraocular Lens
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 269
- 主要终点
- Mean Percent Reduction in Cylinder
研究概览
简要总结
The aims of this study are to:
- Demonstrate a reduction in postoperative cylinder compared to results from the control lens
- Demonstrate better uncorrected distance visual acuity compared to the control lens
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum 18 years of age
- •Cataract for which phacoemulsification extraction and posterior chamber IOL implantation has been planned for both eyes
- •Preoperative best corrected distance visual acuity (BCDVA)of 20/40 or worse (Snellen), with or without glare, for each eye
- •BCDVA projected to be better than 20/30 following cataract removal and IOL implantation for each eye
- •Preoperative keratometric cylinder of 0.75 diopters to 3.62 diopters for each eye (with exception of second eyes with 0.0-0.75 diopters planned to receive non-toric IOL)
- •Clear intraocular media other than cataract in both eyes
- •Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
- •Signed informed consent and HIPAA authorization
排除标准
- •Requiring IOLs outside spherical power range of +15.0 to +28.0 diopters
- •Dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)in either eye
- •Previous corneal or intraocular surgery in either eye
- •Irregular corneal astigmatism in either eye
- •Corneal pathology/abnormality potentially affecting topography in either eye
- •Corneal abnormalities such as stromal, epithelial or endothelial dystrophies in either eye
- •Inability to achieve keratometric stability in either eye for contact lens wearers
- •Subjects with diagnosed degenerative visual disorders in either eye(eg., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
- •Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
- •An eccentric anterior capsulorhexis, zonular damage/rupture or capsular tear/rupture during the cataract extraction procedure
- •Use of systemic or ocular medications that may affect vision
- •Prior, current, or anticipated use during the course of the nine month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo)likely to affect dilation or iris structure
- •Poorly-controlled diabetes
- •Acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
- •Uncontrolled ocular hypertension or glaucomatous changes in the retina or visual field in either eye
- •Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
- •Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
- •Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical trial
研究组 & 干预措施
Control IOL
Active Comparator
Approved Intraocular control lens
干预措施: Tecnis ZCB00 IOL (control) (Device)
Toric IOL
Experimental
Investigational Toric IOL
干预措施: Toric Intraocular lens (Device)
Higher Cylinder Toric IOL
Experimental
Investigational Toric IOLs with higher cylinder powers.
干预措施: Toric Intraocular lens (Device)
结局指标
主要结局
Mean Percent Reduction in Cylinder
时间窗: 6 months after second eye implant compared to baseline
Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.
次要结局
- Uncorrected Distance Visual Acuity (UCDVA)(6 months after second eye implant)
研究者
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