DRKS00014919进行中（未招募）未知
POST-MARKET CLINICAL FOLLOW-UP EVALUATION OF THE TECNIS SYMFONY® plus EXTENDED RANGE OF VISION INTRAOCULAR LENS MODEL ZHR00 - UNISO
Johnson and Johnson Surgical Vision, Inc.0 个研究点目标入组 151 人开始时间: 2018年9月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 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
- 22 Years 至 one（—）
- 性别
- All
入选标准
- •Age 22 and older
- •Bilateral cataracts or crystalline lenses for which posterior chamber IOL implantation has been planned
- •Potential postoperative best corrected distance visual acuity (BCDVA) of 0.66 decimal (20/30 Snellen) or better
- •Predicted postoperative corneal astigmatism less than 1.0 D
- •Clear intraocular media other than cataract in each eye
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Written informed consent for participation in the study and data protection.
排除标准
- •Requiring an intraocular lens power outside the available range of +14.0 to +26.0 D
- •Irregular corneal astigmatism (as evaluated by topography)
- •Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs
- •Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity loss to a level worse than 0.66 decimal (20/30 Snellen) during the study
- •Inability to achieve keratometric stability for contact lens wearers
- •Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- •Subjects with diagnosed degenerative visual disorders that are predicted to cause visual acuity loss to a level worse than 0.66 decimal (20/30 Snellen) 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 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
- •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 Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
- •Known ocular disease or pathology that, in the opinion of the investigator.
- •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 60 days prior to the preoperative visit in any other clinical trial
- •Desire for monovision correction
研究者
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