NCT06594185已完成不适用
A Prospective, Multicenter, Open Label, Single Arm, Post-Marketing Clinical Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 124
- 主要终点
- Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1
研究概览
简要总结
A study to evaluate the real-world clinical performance of the enVista Aspire and Aspire Toric intraocular lens (IOL) models EA and ETA and to assess surgeon and subject satisfaction
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 years of age or older on the date the Informed Consent Form (ICF) is signed.
- •Subjects must be capable of understanding and providing informed consent on the Institutional Review Board (IRB)- approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.
- •Have a BCDVA at or worse than 20/40 in each eye, with or without a glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation.
- •Have a BCDVA projected to be better than 20/30 after IOL implantation in each eye as determined by the medical judgment of the Principal Investigator.
- •Subjects must have clear intraocular media other than the cataract in both eyes.
- •Subjects must require an IOL power from +6.0 diopter (D) to +34.0 diopter (D) in both eyes.
- •Subjects with clinically significant preoperative corneal astigmatism must require an IOL toric power between 1.25 diopter (D) to 5.75 diopter (D).
- •Subjects must be willing and able to comply with all treatment and follow-up Clinical Investigation visits and procedures
排除标准
- •Pre-existing ocular conditions (subjects with prior corneal refractive surgery, irregular corneal astigmatism, severe (clinically significant) corneal dystrophy, e.g., Fuch's, macular disease, optic nerve atrophy, corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, and chronic drug miosis, who may not achieve the visual acuity of patients without such problems, etc.)
- •Associated ocular conditions that could affect the stability of the IOL (e.g., traumaticzonulolysis, zonular dialysis, evident zonular weakness or dehiscence, etc.) in the study eye.
- •Retinal conditions, or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or proliferative diabetic retinopathy, in which future treatment may be compromised by implanting this IOL
- •Rubella, congenital, traumatic, or complicated cataracts
- •Extremely shallow anterior chamber, not due to swollen cataract
- •Recurrent anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction (e.g., iritis or uveitis)
- •Iris neovascularization
- •Subjects who have uncontrolled glaucoma in either eye. Uncontrolled glaucoma is defined as intraocular pressure (IOP) greater than 21 mm Hg in spite of maximally tolerated medications (with more than three topical drugs for IOP control).
- •Microphthalmos or macrophthalmos
- •Previous corneal transplant, prior YAG laser iridotomy, YAG vitreolysis, and prior phakic IOL insertions.
- •Pre-existing ocular conditions that may negatively impact the stability of the implant or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc.).
- •Mechanical or surgical manipulation required to enlarge the pupil
- •Vitreous loss (significant)
- •Anterior chamber bleeding (significant)
研究组 & 干预措施
Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs
Experimental
干预措施: enVista Aspire EA or Aspire Toric ETA IOLs (Device)
结局指标
主要结局
Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1
时间窗: Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)
Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1
Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1
时间窗: Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)
Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1
次要结局
未报告次要终点
研究者
研究点 (124)
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