Outcomes of Combined Cataract Surgery With Retinal Surgery for Visually Significant Epiretinal Membrane With Vivity Versus Monofocal Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 主要终点
- Vision Acuity
研究概览
简要总结
To investigate the patient Quality of Life and satisfaction outcomes of combined cataract surgery with retinal surgery for visually significant epiretinal membrane in patients receiving Vivity IOL versus standard monofocal controls.
详细描述
The information gained by this study will help understand better the suitability of Vivity IOLs for patients with a common retinal condition and potentially expand access and offering of premium IOLs to help patients gain independence from glasses, which can improve quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with visually significant epiretinal membrane who are undergoing or have already had pars plana vitrectomy and membrane peel combined with cataract surgery using Clareon Vivity and Clareon Vivity Toric IOLs or monofocal IOL
- •IOL powers between +6D to +30.0D, T3-T6
排除标准
- •History of ocular or refractive surgery
- •Other ocular or systemic comorbidities that may alter or reduce visual acuity and contrast sensitivity, such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, strabismus/amblyopia etc.
- •Patients with irregular astigmatism, corneal dystrophies, pupil abnormalities, zonular laxity
- •Intraoperative or postoperative complications
研究组 & 干预措施
Vivity Extended Depth of Focus IOL
干预措施: cataract surgery (Device)
Vivity Extended Depth of Focus IOL
干预措施: retinal surgery (Procedure)
Standard monofocal IOL
干预措施: cataract surgery (Device)
Standard monofocal IOL
干预措施: retinal surgery (Procedure)
结局指标
主要结局
Vision Acuity
时间窗: At the study visit at least 3 months after the combined cataract and retinal surgeries
次要结局
- Contrast Sensitivity(At the study visit at least 3 months after the combined cataract and retinal surgeries)
- Patient Reported Outcomes (PRO) on vision-related Quality of Life (QOL) and satisfaction(At the study visit at least 3 months after the combined cataract and retinal surgeries)
研究者
Debbie Kuo, MD
Palo Alto Foundation Medical Group affiliated Ophthalmologist
Sutter Health