NCT07768475进行中（未招募）不适用
A Prospective Study Comparing Visual Outcomes and Patient Satisfaction Following Implantation of the Clareon PanOptix Versus Tecnis Odyssey IOL in Patients Undergoing Cataract Surgery.
Nvision Laser Eye Centers4 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2025年7月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 266
- 试验地点
- 4
- 主要终点
- Binocular BCDVA
研究概览
简要总结
To evaluate visual outcomes and patient satisfaction following bilateral implantation of the Clareon PanOptix versus Tecnis Odyssey IOL in patients undergoing cataract surgery
详细描述
Multi-center, one-arm, ambispective pilot study with Odyssey IOL followed by a multi-center, prospective, randomized, two-arm, double-masked (subject and assessor), Clareon PanOptix vs TECNIS Odyssey comparative study with bilateral IOL implantation (endpoints or sample size may be modified after the pilot data analysis)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to understand and sign informed consent
- •Willing and able to participate with all study testing
- •Adult patient diagnosed with age-related cataracts bilaterally
- •Planned bilateral cataract removal by phacoemulsification with bilateral implantation of the Clareon PanOptix/ Clareon PanOptix Toric or Tecnis Odyssey IOL/ Tecnis Odyssey IOL Toric (T3/4 or DRT150, DRT225)
- •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
- •HOA greater than 0.4 μm within central 4 mm
- •Corneal dystrophies, degenerations, irregular astigmatism or any corneal abnormality aside from regular astigmatism deemed to be of clinical significance by the surgeon.
- •Any pathologic conditions that might affect ease of cataract removal (pseudoexfoliation, posterior polar, etc) as determined by surgeon
- •Strabismus with or without amblyopia in either eye
- •Previous history of any ocular surgery including corneal refractive surgery
- •Presence of any macular disease, history of retinal detachment, or posterior segment abnormality deemed to be of clinical significance by the surgeon.
- •Presence of glaucoma
- •Presence of any acute or chronic systemic disease that would confound the results of this study as determined by the surgeon (e.g. uncontrolled diabetes, immunocompromise, autoimmune disease, etc).
- •Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs).
- •Any subjects with intraoperative complications, including vitreous loss, posterior capsular rupture, zonular dialysis, decentered or tilted IOL, diffuse corneal epithelial defect, and use of iris hooks or expanders, will be excluded from analysis.
研究组 & 干预措施
Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 & 4 (BLF)
Active Comparator
One of 2 IOLs being used in the study
干预措施: Intraocular Lens Implant (Device)
Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225
Active Comparator
One of 2 IOLs being used in the study
干预措施: Intraocular Lens Implant (Device)
结局指标
主要结局
Binocular BCDVA
时间窗: At Visit 2 Month 3
Binocular BCDVA at 4 m under photopic conditions
次要结局
- Visual Acuity(Visit 2 Month 3)
研究者
研究点 (4)
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