A Prospective Study to Evaluate the Safety and Effectiveness of the Supracor Presbyopic Treatment Algorithm for Pseudophakic Eyes Using Lasik
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better
研究概览
简要总结
This clinical study has been planned to determine the effectiveness of a special laser treatment intended to correct both near and distance vision in patients who have undergone previous cataract surgery.
详细描述
This clinical study has been planned to evaluate the safety and effectiveness of the SUPRACOR presbyopic excimer laser treatment algorithm for near myopic and near hyperopic indications, with or without astigmatism, when performed on the cornea of pseudophakic eyes implanted with a monofocal IOL.
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
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be at least 45 years old
- •Subjects must read, understand, and sign an Informed Consent Form (ICF).
- •Subjects must be willing and able to return for scheduled follow-up examinations through 6 months after surgery.
- •Subjects must have undergone previous uncomplicated cataract surgery with monofocal IOL implant in the study eye at least 3 months prior to study enrollment.
- •Subjects must have up to +/- 2.0 (D) of absolute spherical myopia or hyperopia (not spherical equivalent), with up to +/- 2.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction. The spherical equivalent must be no more than +/- 2.0 D.
- •Subjects who have be screened successfully for acceptance of the SUPRACOR simulation
排除标准
- •Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining corneal thickness below the flap postoperatively.
- •Subjects for whom the preoperative assessment of the ocular topography indicates that one or both eyes are not suitable candidates for treatment based upon the suggested computer-simulated treatment plan (e.G. Keratoconus).
研究组 & 干预措施
Supracor
Study arm will consist of patients who have undergone previous cataract surgery with implantation of a monofocal IOL. The Supracor procedure will be performed on the non-dominant pseudophakic eye of these patients.
干预措施: Supracor (Device)
结局指标
主要结局
The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better
时间窗: 6M
次要结局
- The percentage of treated eyes within +/- 1.00D of target refraction(6M)
- The percentage of treated eyes within +/- 0.50D of target refraction(6M)
- The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better(6M)
- Stability analysis: change of ≤ 1D MRSE between two consecutive post-op visits(6M)
- Preservation of VA: Loss of more than 2 lines in BCVA for distance vision(6M)
- The percentage of treated eyes with a best-distance corrected high contrast distance VA of 20/40 or better(6M)
- The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D(6M)
- Cumulative incidence of AEs(6M)
- Cumulative incidence subjective symptoms(6M)