Refractive Accuracy of Toric Intraocular Lens Implantation Using Digital Marking Compared to Conventional Marking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- difference in degrees between the digital marker and the manual marker as measured intraoperatively
研究概览
简要总结
To evaluate the postoperative refractive accuracy and intraoperative lens rotational placement of a conventional toric intraoperative marking method compared to digital marking.
详细描述
Preoperative biometry and planning was assessed with the Argos SS-OCT biometer. The ToriCAM application was also used to mark the patient manually at the bedside. A Mendez marker was used to mark the final axis of the IOL, as calculated by Argos. Digital marking was performed using the VERION image guided system. All subjects received both digital and manual marking, and were implanted with Clareon monofocal toric IOLs (CCWOTx) using the digital marker for final IOL alignment. The primary outcome measure was the difference in degrees between the digital marker and the manual marker as measured intraoperatively. Other outcome measures included IOL rotation, residual astigmatism, absolute prediction error (APE), and monocular visual acuity at 2 months postoperatively.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (50-90 years of age) that were candidates for uncomplicated cataract surgery and planned to be implanted with toric IOLs (CCWOTx, Alcon Vision, LLC)
排除标准
- •History of amblyopia
- •History of macular disease
- •History of glaucoma
- •History of corneal disease
- •History of prior corneal surgery
- •History of diabetes
- •History of ocular comorbidity that might hamper post operative visual acuity
- •History of previous ocular or refractive surgery with expected post-op VA worse than 0.10 logMAR
- •History of irregular corneal astigmatism and keratoconus, or severe/uncontrolled ocular surface disease or dry eye disease.
结局指标
主要结局
difference in degrees between the digital marker and the manual marker as measured intraoperatively
时间窗: From enrollment to the end of post-operative period at 2 months
次要结局
- IOL rotation(From enrollment to the end of post-operative period at 2 months)
- Absolute Prediction Error (APE)(From enrollment to the end of post-operative period at 2 months)
- Monocular Visual Acuity(From enrollment to the end of post-operative period at 2 months)
- Residual Astigmatism(From enrollment to the end of post-operative period at 2 months)
研究者
Ganesha Kandavel
Primary Investigator
Colvard Kandavel Eye Center