Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Cataract
- 发起方
- Alcon Research
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Binocular Visual Acuity at Near, Intermediate and Distance
- 状态
- 终止
- 最后更新
- 14年前
概览
简要总结
The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.
研究者
入排标准
入选标准
- •Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.
排除标准
- •Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
- •All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.
结局指标
主要结局
Binocular Visual Acuity at Near, Intermediate and Distance
时间窗: 6 months after surgery
Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.