NCT07165197招募中不适用
Visual Performance of Clareon® Vivity® and PureSee® Intraocular Lenses in Patients Undergoing Cataract Surgery
OMIQ Research2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年6月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Distance-corrected binocular defocus curve at 4 m
研究概览
简要总结
This is study to determine the visual performance of patients with age-related cataracts implanted in both eyes with either of two extended depth of focus intraocular lenses, the Clareon Vivity (Alcon Healthcare) or the PureSee (Johnson & Johnson)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any sex and race aged 50 years or older
- •Patients undergoing bilateral age-related cataract surgery with a lens opacity grade 3 or higher in the LOCS III grading scale
- •Willing to receive implantation of an EDOF IOL
- •Willing to sign the informed consent and attend the study visits
排除标准
- •Requirement of a spherical or toric power of the IOL to achieve emmetropia beyond the available range of either of the two lenses
- •The number of patients included with low astigmatism that require an equivalent to a T2 toric IOL will be capped to 10 patients/group
- •Irregular astigmatism
- •Contact lens wear in the previous 3 weeks before biometry
- •Moderate or severe ocular surface, corneal, macular or optic nerve disease that in opinion of the investigator precludes the desired functional results
- •History of previous refractive, cornea, retina or glaucoma surgery
- •Eyes with a clear lens demanding a refractive lens exchange
- •Amblyopia in any eye
- •Significant previous ocular trauma
- •Pregnancy
- •A systemic condition that, in the opinion of the investigator, precludes the reliable assessments required in the study (i.e., dementia) or participation in the study (i.e., severe mobility problems).
结局指标
主要结局
Distance-corrected binocular defocus curve at 4 m
时间窗: 3 months
次要结局
- Monocular and binocular, corrected and uncorrected distance, intermediate, and near visual acuities(3 months)
- Distance-corrected contrast sensitivity(Three months)
- Low contrast (25%) binocular distance-corrected visual acuity(3 months)
- Visual dysfunction assessment using the QUVID (Questionnaire for visual disturbances) questionnaire(3 months)
- Spectacle independence assessment using the IOLSAT (Intraocular lens satisfaction) questionnaire(3 months)
研究者
Merce Guarro
MD
OMIQ Research
研究点 (2)
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