Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance).
研究概览
简要总结
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal
详细描述
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have an age-related cataract in both eyes.
- •40 years of age or older.
- •Patient must desire cataract extraction.
- •Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
- •Willing and able to comply with scheduled visits and other study procedures
排除标准
- •Preoperative ocular pathology potentially affecting visual acuity.
- •Keratometric astigmatism exceeding 1.50 diopters.
- •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.
- •Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
- •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.
- •Other ocular surgery at the time of the cataract extraction.
结局指标
主要结局
ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance).
时间窗: Preoperatively, 1, 3 and 6 months postoperatively
次要结局
- pupil size and contrast sensitivity under photopic and mesopic conditions wearing the best distance correction (the latter per eye and both eyes. Slit-lamp exam, eye dominance, reading speed test, and a quality of vision questionnaire.(preoperatively, 1, 3, 6 month)