NCT01714635已完成1 期
Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 36
- 主要终点
- Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •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 or worse (Snellen) with or without a glare source
- •Potential for postoperative best-corrected visual acuity of 20/25 or better
- •Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and no irregular 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 or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
- •Ability to understand and respond to a questionnaire verbally administered in English
排除标准
- •Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D
- •Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
- •Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes
- •Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
- •Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study
- •Inability to achieve keratometric stability for contact lens wearers
- •Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 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, including 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 12-month study of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery
- •Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- •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 outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: ocular hypertension without glaucomatous changes is acceptable.
- •Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other 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 within 30 days prior to preoperative visit in any other clinical trial
- •Desire for monovision correction
结局指标
主要结局
Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm
时间窗: six months
Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative
次要结局
- Mean Diopter Range With VA of 20/40 or Better(six months)
- Spectacle Independence(six months)
研究者
研究点 (36)
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