NCT03856944已完成不适用
Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models
Gainesville Eye Associates2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2018年10月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Residual Refractive Cylinder
研究概览
简要总结
The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery.
详细描述
The objective is to provide a normative standard for refractive and visual outcomes in eyes with significant corneal astigmatism undergoing cataract surgery with the Alcon Toric ReSTOR lens. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible for the study if they meet the following criteria:
- •Note: Ocular criteria must be met in the eligible eye.
- •Bilateral visually-significant cataracts
- •Willing and able to provide written informed consent for participation in the study.
- •Willing and able to comply with scheduled visits and other study procedures.
- •have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
- •Regular corneal astigmatism of 1.00D to 2.50D in both eyes
- •Potential postoperative acuity of 20/25 or better
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Irregular astigmatism (e.g. keratoconus)
- •Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy (EBMD), Fuch's dystrophy, etc.)
- •Monocular status (e.g. amblyopia)
- •Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), lamellar keratoplasty)
- •Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- •Moderate-to-advanced glaucoma
- •Strabismus
- •Use of arcuate incisions for astigmatism management at the time of surgery
- •Diabetic retinopathy
- •Macular pathology (e.g. age-related macular degeneration, epiretinal membrane, etc.)
- •History of retinal detachment
- •Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
- •Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- •The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- •Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
结局指标
主要结局
Residual Refractive Cylinder
时间窗: 3 months
Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation
次要结局
- Binocular Uncorrected Distance Visual Acuity(3 months)
- IOL Orientation(3 months)
- Monocular Uncorrected Near Visual Acuity(3 months)
- Monocular Uncorrected Intermediate Visual Acuity(3 months)
- Binocular Uncorrected Intermediate Visual Acuity(3 months)
- Binocular Best-corrected Distance Visual Acuity(3 months)
- Binocular Best Distance-corrected Intermediate Visual Acuity(3 months)
- Binocular Best Distance-corrected Near Visual Acuity(3 months)
- Subjective Visual Quality(3 months)
- Monocular Best Distance-corrected Intermediate Visual Acuity(3 months)
- Binocular Uncorrected Near Visual Acuity(3 months)
- Binocular Best Distance-corrected Defocus Curve(3 months)
- Monocular Uncorrected Distance Visual Acuity(3 months)
- Monocular Best Corrected Distance Visual Acuity(3 months)
- Monocular Best Distance-corrected Near Visual Acuity(3 months)
- Binocular Uncorrected Defocus Curve.(3 months)
研究者
Clayton Blehm, MD
Principal investigator
Gainesville Eye Associates
研究点 (2)
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