NCT02203721已完成不适用
Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00
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
- 324
- 试验地点
- 15
- 主要终点
- Uncorrected Intermediate Visual Acuity
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 22 years of age
- •Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
- •Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
- •Potential for postoperative BCDVA of 20/30 Snellen or better
- •Corneal astigmatism
- •Clear intraocular media, other than cataract
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Signed informed consent and HIPAA authorization
- •Ability to understand and respond to a questionnaire in English or Spanish
排除标准
- •Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D
- •Pupil abnormalities
- •Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- •Prior corneal refractive or intraocular surgery
- •Corneal abnormalities
- •Inability to achieve keratometric stability for contact lens wearers
- •Subjects with diagnosed degenerative visual disorders that are predicted to cause visual acuity losses to a level of 20/30 Snellen or worse during the study
- •Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
- •Use of systemic or ocular medications that may affect vision
- •Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin, that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject
- •Inability to focus or fixate for prolonged periods of time
- •Poorly-controlled diabetes
- •Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study.
- •May be expected to require retinal laser treatment or other surgical intervention during the course of the study
- •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 within 30 days prior to preoperative visit in any other clinical trial
- •Desire for monovision correction
研究组 & 干预措施
TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
Experimental
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
干预措施: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 (Device)
TECNIS Monofocal IOL, Model ZCB00
Active Comparator
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
干预措施: TECNIS Monofocal IOL, Model ZCB00 (Device)
结局指标
主要结局
Uncorrected Intermediate Visual Acuity
时间窗: 6 months
Uncorrected Intermediate Visual Acuity at 6 months.
Distance Corrected Intermediate Visual Acuity
时间窗: At 6 months
FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
次要结局
未报告次要终点
研究者
研究点 (15)
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