Prospective Clinical Study to Evaluate the Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Binocular Uncorrected Distance Visual Acuity (UDVA)
研究概览
简要总结
This is a prospective, comparative, randomized, controlled, open-label, single-surgeon, single-center PMCF clinical study whereby presbyopic patients undergoing refractive surgery will receive a SUPRACOR treatment for the correction in the non-dominant eye and a PROSCAN refractive treatment in the dominant eye to correct for ametropia.
The participants will be randomized to either a SUPRACOR regular (100%) or SUPRACOR strong (130%) treatment with a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presbyopia
- •willingness for a refractive presbyopia correction
- •signed informed consent form
排除标准
- •ocular comorbidity
研究组 & 干预措施
SUPRACOR Regular
干预措施: SUPRACOR Regular (Procedure)
SUPRACOR Strong
干预措施: SUPRACOR Strong (Procedure)
结局指标
主要结局
Binocular Uncorrected Distance Visual Acuity (UDVA)
时间窗: 3 months follow up
The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.
次要结局
- Glare Photic phenomena(3 months follow up)
- Binocular Corrected Distance Visual Acuity (CDVA)(3 months follow up)
- Binocular Contrast sensitivity(3 months follow up)
- Binocular Uncorrected Near Visual Acuity (UNVA)(3 months follow up)
- Monocular Corrected Distance Visual Acuity (CDVA)(3 months follow up)
- Monocular Uncorrected Intermediate Visual Acuity (UIVA)(3 months follow up)
- Binocular Uncorrected Intermediate Visual Acuity (UIVA)(3 months follow up)
- Monocular Uncorrected Near Visual Acuity (UNVA)(3 months follow up)
- Binocular Defocus Curve(3 months follow up)
- Halo Photic phenomena(3 months follow up)
- Monocular Uncorrected Distance Visual Acuity (UDVA)(3 months follow up)
- Patient-Reported Spectacle Independence Questionnaire (PRSIQ)(3 months follow up)
- Near Activity Visual Questionnaire (NAVQ)(3 months follow up)