NCT01190631已完成不适用
An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation After SN60WF IOL Implantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Contrast Sensitivity
研究概览
简要总结
The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL implantation, and to determine if an association exists between TSA, postoperative high order aberrations (HOA), and functional vision following IOL implantation in patients grouped by pre-operative corneal spherical aberration (CSA).
详细描述
Patients will be grouped by pre-operative corneal spherical aberration (CSA) measures, i.e., ≤0.230 micron and ≥0.270 micron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age-related cataract grade 3 or lower in at least one eye;
- •Planned cataract removal via phacoemulsification with an implantation of an aspheric IOL;
- •Able to have an operation within 30 days of preoperative evaluation;
- •Good ocular health, with the exception of cataracts;
- •≤ 1.50 diopter (D) of preoperative astigmatism by keratometry;
- •Willing and able to understand and sign an informed consent;
- •Willing and able to attend postoperative examinations per protocol schedule;
- •Able to achieve 6.5mm dilated pupil;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Preoperative ocular pathology as specified in protocol;
- •Preoperative corneal pathology as specified in protocol;
- •Keratometric astigmatism exceeding 1.50 diopter;
- •Planned postoperative refraction for mono-vision;
- •Uncontrolled diabetes;
- •Use of any systemic or topical drug known to interfere with visual performance;
- •Contact lens use during the active treatment portion of the trial;
- •Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis;
- •Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results;
- •Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial;
- •Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye;
- •Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Contrast Sensitivity
时间窗: Day 90 postoperative
Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
次要结局
- Total Higher Order Aberrations(Day 90 postoperative)
- Corneal Spherical Aberration(Day 90 postoperative)
- Uncorrected Visual Acuity (UCVA)(Day 90 postoperative)
- Best Corrected Visual Acuity (BCVA)(Day 90 postoperative)
- Low Contrast (10%) Visual Acuity(Day 90 postoperative)
- Quality of Vision Questionnaire(Day 90 postoperative)
研究者
研究点 (2)
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