DRKS00015756已完成4 期
A PROSPECTIVE COMPARATIVE POST MARKET CLINICAL FOLLOW-UP STUDY TO EVALUATE THE EFFECTIVNESS OF THE HOYA VIVINEX™ PRE-LOADED TORIC INTRAOCULAR LENSES - VIVT-103-MORE
Hoya Medical Singapore PTE. LTD.0 个研究点目标入组 299 人开始时间: 2018年10月17日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 299
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
- Open (masking not used)
入排标准
- 年龄范围
- 22 Years 至 one（—）
- 性别
- All
入选标准
- •1. Adult subjects with a minimum age of 22 years
- •2. Planned for first eye cataract extraction or natural lens removal with implantation of a toric IOL
- •3. Corneal astigmatism in at least one eye between 0.7D to 4.5D (1.0D and 6.0D at IOL plane).
- •4. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
- •5. Clear intraocular media other than cataract in the study eye
- •6. Expected postoperative BCDVA of 0.2 LogMAR or better in the study eye
- •7. Expected postoperative pharmacologically dilated pupil diameter of 5.5 mm or greater
- •8. Signed informed consent
排除标准
- •1. Requiring an intraocular lens outside the available spherical and cylindrical power range
- •2. Preoperative previous intraocular and corneal surgery, including corneal refractive surgery, or retinal surgery on the study eyes
- •3. Traumatic cataract in study eyes
- •4. Strabismus, Amblyopia or Single Eye status
- •5. Pupil abnormalities (e.g., non-reactive, fixed pupils, or bnormally shaped pupils)
- •6. Irregular corneal astigmatism
- •7. Contact lens wear within 6 months of the preoperative examination for PMMA contact lenses, within 1 month of the preoperative examination for gas permeable lenses, or within 3 weeks of the preoperative examination for extended-wear and daily-wear soft contact lenses in the study eye
- •8. Presence of corneal pathology affecting topography (e.g. stromal, epithelial or endothelial dystrophy)
- •9. Acute, chronic, or uncontrolled systemic or ocular disease or illness that would increase the operative risk or confound the outcome of the study (e.g. poorly-controlled diabetes, immunocompromised, connective tissue disease, uncontrolled ocular hypertension, glaucomatous changes in the retina, chronic iritis/uveitis, retinal vessel disease, Sicca syndrome, etc.) or where healing processes are compromised
- •10. 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
- •11. Pregnant, plan to become pregnant, are lactating or have another condition associated with the fluctuation of hormones that could lead to significant refractive changes
- •12. Concurrent participation in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
- •Intraoperative exclusion criteria:
- •1. Intraoperative application of parasympatholytica e.g. atropine, tropicamide, etc., for pupil dilation
研究者
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