NCT07610226招募中不适用
Post-refractive IOL Outcomes With Clareon TruPlus
Laser Defined Vision1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2026年6月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
This is a prospective, single-arm, single-center, single-surgeon study evaluating the Clareon TruPlus IOL in post-refractive cataract patients. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the PRISQ Questionnaire.
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
- •Willing and able to understand and sign informed consent.
- •Adult patients (>45 years old) undergoing age-related cataract surgery that previously had myopic corneal refractive surgery.
- •Dominant eye targeted for emmetropia, non-dominant eye may be targeted for ≤-0.75D (mini-monovision).
- •Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon.
- •Normal ocular findings aside from cataract.
排除标准
- •Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
- •Previous history of any ocular surgery, except for myopic LASIK or PRK.
- •Previous hyperopic refractive surgery.
- •Corneal HOA ≥1.0 µm (RMS) with OPD at 4mm scan.
- •Any active ocular infection or inflammation.
研究组 & 干预措施
Clareon TruPlus
干预措施: Clareon TruPlus (Device)
研究者
研究点 (1)
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