Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Binocular Best Corrected Distance Visual Acuity
研究概览
简要总结
This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT***/CCWET*).
Patients will be assessed for monocular and binocular distance, intermediate, and near vision.
详细描述
This is a non-interventional, prospective, single center, bilateral, observational study of the outcomes for 40 post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT***/CCWET*) performed by 4 surgeons using similar surgical techniques. 40 subjects will be enrolled.
Patients will be assessed for monocular and binocular distance, intermediate, and near vision.
The hypothesis is that post-refractive patients that have high spherical aberration (SAs) will have excellent outcomes and satisfaction with a Vivity IOL
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adults, 40 years of age having already undergone cataract removal by phacoemulsification with a clear corneal incision in both eyes with implantation of the Vivity IOL (DAT***/CCWET*)
- •Prior uncomplicated, distance-targeted, bilateral myopic LASIK or PRK (photorefractive keratectomy) surgery and corneal spherical aberration greater than ≥0.30 μ and ≤ 1.20 μ in at least one eye (6.00 mm) as measured at their cataract pre-op visit
- •Able to comprehend and willing to sign informed consent and complete all required testing procedures
- •Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
- •Clear intraocular media
- •Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
- •Residual refractive astigmatism ≤0.50 diopters
- •Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent
排除标准
- •Any corneal abnormality, other than regular corneal astigmatism or myopic LASIK/PRK surgery, (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
- •Any complication during cataract surgery (capsular tear, vitrectomy, etc)
- •History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
- •Amblyopia or strabismus in either eye
- •History of or current anterior or posterior segment inflammation of any etiology
- •Any form of neovascularization on or within the eye
- •Glaucoma (uncontrolled or controlled with medication)
- •Optic nerve atrophy
- •Subjects with diagnosed degenerative eye disorders
- •Postoperative CDVA worse than 0.10 logMAR in either eye.
- •Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)
结局指标
主要结局
Binocular Best Corrected Distance Visual Acuity
时间窗: 3 weeks post operatively
Binocular Best Corrected Distance Visual Acuity in logMAR
次要结局
- Monocular Visual Acuity(3 weeks post operatively)
- Binocular Distance, Intermediate, and Near Visual Acuity(3 weeks post operatively)
- Quality of Vision After Surgery (QUVID) Questionnaire(3 weeks post operatively)
- Intraocular Lens Satisfaction (IOLSAT) Questionnaire(3 weeks post operatively)
- Post-op Refraction(3 weeks post operatively)