NCT06122103已完成不适用
Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens
Gainesville Eye Associates1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2023年11月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Binocular Corrected Distance Visual Acuity (CDVA)
研究概览
简要总结
This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 patients undergoing age-related cataract surgery with expected best- corrected visual outcomes of 20/25 or better
- •Regular corneal astigmatism of 0.75D-2.50D
- •Dilated pupil diameter of 7mm or greater
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.
- •Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, history of uveitis, ocular herpes simplex virus, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
- •History of corneal refractive and intraocular surgery.
- •Patients taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina.
- •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.
研究组 & 干预措施
Clareon Monofocal
干预措施: Clareon Monofocal (Device)
Light-Adjustable Lens
干预措施: Light-Adjustable Lens (Device)
结局指标
主要结局
Binocular Corrected Distance Visual Acuity (CDVA)
时间窗: 3 months postop
次要结局
- Binocular Uncorrected Distance Visual Acuity (UDVA)(3 months postop)
- Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)(3 months postop)
- Binocular Uncorrected Intermediate Visual Acuity (UIVA)(3 months postop)
- Monocular Corrected Distance Visual Acuity (CDVA)(3 months postop)
- Monocular Uncorrected Distance Visual Acuity (UDVA)(3 months postop)
- Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)(3 months postop)
- Monocular Uncorrected Intermediate Visual Acuity (UIVA)(3 months postop)
研究者
研究点 (1)
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