NCT05526781已完成不适用
Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System
Eye Consultants of Atlanta1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年9月21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
- 34
- 试验地点
- 1
- 主要终点
- Monocular Corrected Distance Visual Acuity (6m)
研究概览
简要总结
To evaluate visual outcomes, in-the-bag placement and patient satisfaction in patients implanted with either Clareon monofocal or Clareon monofocal toric IOLs with the Monarch IV inserter and targeted for emmetropia.
详细描述
This study is a single-arm clinical evaluation study of visual performance and patient satisfaction, after successful bilateral cataract surgery. Subjects will be assessed pre- operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and IOLSAT questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.
- •Adult cataract surgical patients over the age of 45 with visually significant bilateral cataracts (glare visual acuity 20/40 or worse with BCVA testing), with planned cataract extraction using phacoemulsification, clear corneal incision and Clareon monofocal or Clareon toric with Monarch IV.
- •Able to provide written informed consent for participation in the study.
- •All eyes will be in the range of availability for Clareon monofocal and Clareon toric with Monarch IV.
- •Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.
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.
- •Visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
- •History of neovascular AMD, diabetic macular edema, unstable proliferative diabetic retinopathy, geographic atrophy, branch retinal artery or branch retinal vein occlusion, central retinal artery or central retinal vein occlusion, moderate to severe epiretinal membrane, severe dry eye.
- •History of intraocular infection including HSV keratitis, VZV keratitis, endophthalmitis.
- •History of previous ocular surgery, including corneal refractive surgery, eye trauma or retinal detachment surgery.
- •History of rheumatoid arthritis, ocular cicatricial pemphigoid, or Steven's Johnson Syndrome.
- •History of glaucoma.
- •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
Monocular Corrected Distance Visual Acuity (6m)
时间窗: 3 months postoperative
Monocular Uncorrected Distance Visual Acuity (6m)
时间窗: 3 months postoperative
Binocular Uncorrected Distance Visual Acuity (6m)
时间窗: 3 months postoperative
Binocular Corrected Distance Visual Acuity (6m)
时间窗: 3 months postoperative
次要结局
- Monocular Uncorrected Intermediate Visual Acuity (66cm)(3 months postoperative)
- Binocular Uncorrected Intermediate Visual Acuity (66cm)(3 months postoperative)
- Binocular Distance Corrected Intermediate Visual Acuity (66cm)(3 months postoperative)
- Monocular Distance Corrected Intermediate Visual Acuity (66cm)(3 months postoperative)
- Manifest Refraction Spherical Equivalent (MRSE)(3 months postoperative)
- Overall Surgeon Satisfaction of Monarch IV Delivery Experience(Operative visit (Day 0))
- Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV(Operative visit (Day 0))
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Comparison of visual outcomes and patient satisfaction after implantation of non-diffractive extended depth of focus and aspheric monofocal intraocular lenses with monovision: a randomised trialpseudophakic presbyopiaEye - Diseases / disorders of the eyeCataractastigmatismACTRN12623000124639Dr Graham Hay-Smith110
已完成
不适用
Monofocal IOL Visual Outcomes When Targeting Mini MonovisionCataractPresbyopiaNCT05069415Carolina Eyecare Physicians, LLC75
已完成
不适用
Comparision of Visual Outcomes and Patient Satisfaction Between Two Diffractive Trifocal Intraocular LensesCataract SenileNCT04655274Akdeniz University30
已完成
不适用
EDOF and Multifocal IOL StudyAge-related CataractNCT05573529Medical University of Vienna50
终止
不适用
Visual Outcomes After Vivity Toric IOL ImplantationRefractive AssessmentNCT04675489EVP Eye Care4