NCT07006428招募中不适用
Visual Performance Differences Between Clareon PanOptix and a Comparable Multifocal Intraocular Lens
Argus Research Center, Inc.6 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2025年5月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 290
- 试验地点
- 6
- 主要终点
- Binocular photopic BCDVA (4m)
研究概览
简要总结
This is a two-part, multi-center, investigator-initiated clinical study comparing visual outcomes and patient satisfaction in subjects receiving bilateral implantation of either the Clareon PanOptix intraocular lens (IOL) or a comparable multifocal IOL. The study includes a retrospective/prospective pilot phase and a prospective, randomized comparison phase.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 1: IIT Pilot
- •Willing and able to understand and sign informed consent.
- •Adult patients previously diagnosed with age-related cataracts bilaterally.
- •Previous bilateral age-related cataract removal and with bilateral implantation of the Clareon PanOptix/ Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4) closest to 2.5-5-months after implantation and >2 weeks post YAG (if done) that were targeted for emmetropia.
- •Best monocular corrected distance visual acuity was 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.
- •Stage 2: Comparison
- •Willing and able to understand and sign informed consent.
- •Adult patient diagnosed with age-related cataracts bilaterally.
- •Planned bilateral cataract removal by femtosecond laser-assisted phacoemulsification with bilateral implantation of the Clareon PanOptix/Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4).
- •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).
- •Normal ocular findings aside from cataract.
排除标准
- •Stage 1: IIT Pilot
- •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 including corneal refractive surgery.
- •Participation in another clinical study that could interfere with the results.
- •Patients with monovision correction.
- •Any active ocular infection or inflammation.
- •Stage 2: Comparison
- •Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative
- •diseases 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 including corneal refractive surgery.
- •Participants desiring monovision.
- •History of amblyopia or monofixation syndrome with poor stereoscopic vision.
- •Total corneal HOA greater than 0.6um, coma less than 0.3um at 4mm-5mm scan depending on pre- op photopic topography.
- •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.
结局指标
主要结局
Binocular photopic BCDVA (4m)
时间窗: 2.5 to 5 months postoperatively
Binocular BCDVA (4m)
时间窗: Month 3
次要结局
未报告次要终点
研究者
研究点 (6)
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