NCT07790887尚未招募4 期
A Prospective, Single-Arm Clinical Evaluation of Visual, Refractive, and Patient-Reported Outcomes Following Bilateral Implantation of the TECNIS PureSee™ Extended Depth of Focus Intraocular Lens
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Monocular and binocular uncorrected distance visual acuity (UCDVA) at 1-3 months postoperatively
研究概览
简要总结
Assess the visual, refractive, and patient-reported outcomes - including spectacle independence - of bilateral cataract surgery with implantation of the TECNIS PureSee extended depth of focus (EDOF) IOL in subjects with visually significant cataract in a real-world setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥40 years with bilateral visually significant cataracts electing to undergo cataract surgery
- •Calculated IOL power within the available PureSee power range
- •Both eyes targeted for plano (first minus recommended) in both eyes
- •Preoperative corneal astigmatism ≤0.75 D for non-toric PureSee, or within the treatment range of the PureSee Toric platform
- •Potential postoperative best-corrected distance visual acuity of 20/25 or better in each eye
- •Willing and able to comply with the scheduled visits and study procedures
排除标准
- •Prior intraocular or corneal refractive surgery in the operative eye(s)
- •Irregular corneal astigmatism, keratoconus, pellucid marginal degeneration, or other ectatic disease
- •Clinically significant macular pathology, advanced glaucoma with field loss, amblyopia, or any concurrent ocular condition that would limit BCVA at the discretion of the investigator
- •Pupil abnormalities, zonular instability, pseudoexfoliation, or any condition predisposing to intraoperative or postoperative IOL instability
- •History of ocular trauma or uveitis
- •Uncontrolled systemic disease that in the opinion of the investigator would interfere with study participation or healing
结局指标
主要结局
Monocular and binocular uncorrected distance visual acuity (UCDVA) at 1-3 months postoperatively
时间窗: 1 month and 3 months post cataract surgery
Monocular and binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm
时间窗: 3 months post cataract surgery
Patient-reported spectacle independence for distance, intermediate, and near tasks assessed via validated questionnaire (AIOLIS questionnaire)
时间窗: 3 months post cataract surgery
次要结局
- Monocular and binocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months postoperatively(3 months post cataract surgery)
- Manifest refraction spherical equivalent (MRSE) and percentage of eyes within ±0.50 D and ±1.00 D of the refractive target(3 months post cataract surgery)
- Rate (%) of visual disturbances using the AIOLIS validated questionnaire(3 months post cataract surgery)
研究者
研究点 (1)
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