NCT06041139已完成不适用
Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm
研究概览
简要总结
Background:
- The Tecnis Synergy intraocular lens (IOL) has a claim to allow patients to experience continuous high-contrast vision from far through near even in low-light conditions.
- A J&J-sponsored post marketing study done outside of the US claim superiority of range of vision for the Tecnis Synergy IOL over the PanOptix IOL.
Hypothesis:
- Patients with bilateral Panoptix IOLs have non-inferior distance, intermediate, and near visual acuity compared to patients with bilateral Synergy IOLs in both photopic and mesopic conditions with less glare, haloes, and/or starbursts.
Unmet Medical Need:
- There is a need to look at patient visual outcomes and the visual disturbance profile comparing trifocal technology with combined EDOF/Bifocal technology in the United States.
详细描述
- This is a non-interventional single center, two-arm comparative study of the outcomes for patients following successful, uncomplicated cataract surgery.
- There will be 155 subjects enrolled in each arm (310 subjects total).
- Consecutive screening will be used for enrollment beginning from the first bilateral IOL implanted.
- All testing will be at a single site with subjects coming from 4 surgeons (all use similar surgical technique) at that site.
- Each surgeon will contribute a minimum of ten subjects per arm.
- Subjects will be assessed post-operatively during a minimum of five months after their second-eye surgery.
- Binocular defocus curves will be performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
- Self-reporting of visual complaints will be assessed.
- IOLSAT (IOL Satisfaction) and QUVID (Quality of Vision After Surgery) questionnaire will be administered at the study visit.
- Halo and Glare simulator VS Halo & Glare (visu-med.com) will be administered at the study visit.
- All visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked.
- PanOptix subjects will have been implanted with the toric and non-toric models.
- Synergy subjects will have been implanted with the toric and non-toric models.
- Demographic data will be collected to match the groups as closely as possible.
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
- •Are willing and able to understand and sign an informed consent
- •Are willing and able to complete all required study visits
- •Are more than 40 years of age
- •Patient diagnosed with cataracts both eyes and underwent uncomplicated cataract surgeries
- •Patients with bilateral PanOptix (toric or non-toric)
- •Patients with bilateral Synergy (toric or non-toric)
- •Post-op best Corrected distance Visual Acuity for each eye is logMAR 0.1 (20/25) or better after cataract removal.
- •Post-op residual refractive error +0.50 - -0.50 SE with ≤ 0.75 residual refractive astigmatism in each eye
- •Minimum of two weeks post Yttrium Aluminum Garnet capsulotomy to treat posterior capsular opacification
排除标准
- •Corneal dystrophies or degenerations
- •Failure to return for follow up at designed intervals.
- •Any conditions that might affect cataract removal (pseudoexfoliation, posterior polar cataract, Flomax, etc.)
- •Any conditions during surgery that might prolong the cataract removal (capsular tear, inadequate pupil dilation, etc.)
- •Strabismus with or without amblyopia in either eye
- •Previous ocular surgery of any kind
- •History of retinal detachment
- •Any corneal abnormality, other than regular corneal astigmatism (as determined by corneal topography) that in the opinion of the investigator would confound the outcome(s) of the study
- •Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that in the opinion of the investigator is clinically significant
- •Subjects with glaucoma
- •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, etc)
结局指标
主要结局
Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm
时间窗: 3 months post operatively
Binocular DCNVA Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
次要结局
- Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE).(3 months post operatively)
- Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m.(3 months post operatively)
- Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm.(3 months post operatively)
- Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m.(3 months post operatively)
- Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm.(3 months post operatively)
- Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm.(3 months post operatively)
- Binocular Target Corrected Defocus Curve(3 months post operatively)
- Patient Reported Satisfaction by IOLSAT Questionnaire.(3 months post operatively)
- Patient Reported Dysphotopsias Questionnaire (QUVID).(3 months post operatively)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
EDOF and Multifocal IOL StudyAge-related CataractNCT05573529Medical University of Vienna50
终止
不适用
Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic MaterialCataractNCT05488769Thomas Nagy6
终止
不适用
Patient Satisfaction and Visual Outcomes After Bilateral PanOptix Implantation in Patients With Previous Multifocal Contact LensCataractNCT05518227Vivid Laser Center12
已完成
不适用
Patient Preference and Visual Quality With Contralateral Synergy Versus PanoptixIOLPatient SatisfactionCataractNCT05610540Bucci Laser Vision Institute20
已完成
不适用
Comparison of Visual Performance and Patient Satisfaction after Multifocal Intraocular Lens Implantation and Multifocal Contact Lens after Monofocal Intraocular Lens Implantation.Presybyopia after Cataract SurgeryJPRN-UMIN000045132Kitasato University142