NCT07658040招募中不适用
Visual and Patient Reported Outcomes Comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in Normal Cataract Patients: Stage 1
Gainesville Eye Associates2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年7月20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
- 70
- 试验地点
- 2
研究概览
简要总结
This study is a prospective, randomized, two-arm, single-center, single-surgeon, double-masked (subject and assessor) comparative study. It involves bilateral implantation of intraocular lenses (IOLs), comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in normal cataract patients. The study will be conducted at one site and will include a pre-operative visit and a 3-month post-operative assessment.
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 patient diagnosed with age-related cataracts bilaterally.
- •Planned bilateral cataract removal and with bilateral implantation of the Clareon TruPlus IOL/Toric BLF (T3-T5) or Tecnis Eyhance IOL/Eyhance Toric (equivalent to T3-T5).
- •Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon.
- •Residual astigmatism expected to be <= 0.50 diopters in both eyes postoperatively as determined by surgeon (After using either toric IOL or arcuate incision with laser or manual LRI).
- •Normal ocular findings aside from cataract.
排除标准
- •Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
- •Previous history of any ocular surgery including corneal refractive surgery.
- •History of amblyopia or monofixation syndrome with poor stereoscopic vision.
- •Participants desiring monovision.
- •Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs).
- •Participation in another clinical study that could interfere with the results.
- •Any active ocular infection or inflammation.
研究组 & 干预措施
Tecnis Eyhance
干预措施: Tecnis Eyhance (Device)
Clareon TruPlus
干预措施: Clareon TruPlus (Device)
研究者
研究点 (2)
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