Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the AcrySof® Vivity Intraocular Lens With a Target of Slight Myopia in the Non-dominant Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Binocular Near Visual Acuity
研究概览
简要总结
The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.
详细描述
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
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
- 是
入选标准
- •• Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an EDF IOL
- •Meet the requirements for on-label implantation of the EDF IOL
- •Gender: Males and Females.
- •Age: 40 or older.
- •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)
- •Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or toric IOL.
- •Have 20/32 (0.2 logMAR) or better potential acuity in both eyes
排除标准
- •• Irregular astigmatism (e.g. keratoconus)
- •Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)
- •Monocular status (e.g. amblyopia)
- •Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
- •Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- •Diabetic retinopathy
- •Macular pathology (e.g. ARMD, ERM)
- •History of retinal detachment
- •Subjects who have an unstable 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 any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).
结局指标
主要结局
Binocular Near Visual Acuity
时间窗: 3 months postop
binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.
次要结局
- Prediction Accuracy(3 months postop)
- Spectacle Independence(3 months postop)
- Patient Spectacle Independence(3 months postop)
- Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"(3 months postop)
- Manifest Refraction(3 months postop)
- Residual Cylinder(3 months)
- Uncorrected Distance Visual Acuity(3 months postop)
- Uncorrected Intermediate Visual Acuity(3 months postop)
- Uncorrected Near Visual Acuity(3 months postop)
- Corrected Distance Visual Acuity(3 months postop)
- Distance Corrected Intermediate Visual Acuity(3 months postop)