NCT06574646尚未招募不适用
Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
The Eye Associates2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
研究概览
简要总结
Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs
Phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Subjects will be randomized in a 1:1 manner to LAL+ or Clareon VIvity Toric IOLs.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥45) subjects who are astigmatic and require bilateral, routine small-incision, surgery for age-related cataracts with femtosecond laser;
- •All subjects will be required to be targeted for refractive emmetropia (plano or first minus closest to plano);
- •Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator;
- •Subjects will have regular corneal astigmatism (1.00 to 2.00 D), which can be corrected with a toric power IOL of T3-T5;
- •Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes;
排除标准
- •Moderate-severe corneal pathology;
- •Irregular astigmatism;
- •Subject desire monovision correction;
- •Preexisting macular disease or other retinal degenerative diseases that is expected to cause future vision loss;
- •History of glaucoma;
- •Severe dry eye disease;
- •History of uveitis;
- •History of ocular herpes simplex virus;
- •History of nystagmus;
- •Zonular laxity or dehiscence;
- •History psueudoexfoliation;
- •History of corneal refractive and intraocular surgery or requiring any other planned ocular surgical procedures;
- •Currently taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina;
- •Pregnant or breastfeeding.
结局指标
主要结局
Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
时间窗: at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for LAL+ implanted subjects and >2 weeks post YAG, if done.
Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
次要结局
未报告次要终点
研究者
Cathleen McCabe MD
Medical Director
The Eye Associates
研究点 (2)
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