DRKS00010603已完成未知
Clinical Investigation of the TECNIS® Eyhance Intraocular Lens, Model ICB00 - EDOF-111-QTRE
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 151
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 one（—）
- 性别
- All
入选标准
- •Minimum 50 years of age
- •Bilateral cataracts or planned natural lens removal (due to immature cataract) for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
- •Potential for postoperative best corrected visual acuity of Decimal 0.8 (Snellen 20/25) or better
- •Corneal astigmatism:
- •o Normal corneal topography and no irregular corneal astigmatism
- •o Preoperative corneal astigmatism of 1.00 D or less in both eyes
- •Clear intraocular media, other than cataract
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Signed informed consent and any other documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
- •Ability to understand, read and write English, German or Spanish
排除标准
- •Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
- •Any ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- •Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) surgery
- •Corneal irregularities or abnormalities including stromal, epithelial or endothelial dystrophies that are anticipated to cause visual acuity losses
- •Endothelial cell count < 2000 cells/mm2
- •Contact lens wearers within 6 months of the preoperative visit
- •Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are anticipated to cause visual acuity losses
- •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 or other surgical complications
- •Use of systemic or ocular medications that may affect vision, including miotic agents
- •Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
- •Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- •Intraocular inflammation or recurrent ocular inflammatory condition
- •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 (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
- •Known ocular disease or pathology that may affect visual acuity (e.g. amblyopia, retinal vein occlusion etc.)
- •Known ocular disease 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.)
- •Desire for monovision correction
- •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. Women of childbearing age must undergo a pregnancy test to ensure no pregnancy at the time of signing the subject informed consent
- •Requiring an intraocular lens power outside the available range of +16.0 D
- •to +28.0 D
- •Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial
研究者
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