DRKS00004740已完成未知
Market Assessment Clinical Study of expanded Design of the Tecnis® Multifocal 1-Piece IOL - DIOL-107-ZMLA
AMODebbie Trentacost0 个研究点目标入组 31 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Minimum 18 years of age
- •Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned
- •Potential for postoperative best-corrected visual acuity of 20/25 or better
- •Preoperative corneal astigmatism of 1.0 D or less with no irregular astigmatism
- •Clear intraocular media, other than cataract
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Signed informed consent to comply with applicable privacy laws pertaining to medical treatment in the governing countries
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
- •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.)
- •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
研究者
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