Refractive and Visual Outcomes With the ARGOS Biometer In Eyes With a History of Refractive Surgery: ARGOS Study
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
- Refractive Outcomes
研究概览
简要总结
The study is to evaluate the visual and refractive outcomes in eyes with prior myopic refractive surgery undergoing cataract surgery for intraocular lens (IOL) power calculations.
详细描述
This was a prospective, single-site, study evaluating the accuracy of the ARGOS biometer in subjects with a history of myopic corneal refractive surgery including Laser-Assisted In Situ Keratomileusis (LASIK) and Photorefractive Keratectomy (PRK).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing uncomplicated cataract surgery with a history of myopic corneal laser refractive surgery
- •Subjects electing to undergo implantation with a monofocal/non-toric IOL
- •Willing and able to comprehend informed consent and complete an 8-week visit.
- •Potential postoperative Corrected Distance Visual Acuity (CDVA) of 20/20 or better in each eye based on Investigator's medical opinion
排除标准
- •Concurrent or prior ocular surgery within the previous 12 months.
- •Ocular comorbidity that could reduce the potential postoperative CDVA based on the discretion of the operating surgeon
- •History of hyperopic laser corneal refractive surgery
- •History of radial keratotomy
- •Irregular corneal astigmatism or keratoconus
- •Eyes with intraoperative or postoperative complications
- •Eyes with BCDVA worse than 20/100 preoperatively
- •Subjects who are pregnant or plan to become pregnant during the course of the study.
结局指标
主要结局
Refractive Outcomes
时间窗: 12 weeks
To evaluate refractive outcomes in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations.
Visual Outcomes
时间窗: 12 weeks
To evaluate visual in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations.
次要结局
未报告次要终点