NCT06597292尚未招募不适用
Vision Improvement for Patients With Presbyopia
VIS, Inc.4 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2024年9月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Uncorrected Distance Visual Acuity (UDVA)
研究概览
简要总结
The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patient IDs will be assigned and used.
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
- •Subjects who meet all of the following criteria are candidates for this study:
- •Male or Female
- •Patient is at least 40 years old.
- •Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
- •Patient has manifest refraction, spherical equivalent (MRSE) between -0.50 D to 2.50 D, with no more than 1.0 D of refractive cylinder, in eye(s) to be treated.
- •Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes.
- •Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
- •Patient has uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR < 0.70) in eye(s) to be treated.
- •Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.
- •Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.
- •Patient is not a contact lens (CL) wearer.
- •Patient has normal corneal topography.
- •Patient is willing and able to comply with all examinations.
- •Patient must be competent to sign an informed consent form before study entry.
排除标准
- •Subjects who meet any of the following criteria are to be excluded from this study:
- •Corneal disease or corneal disorder in either eye.
- •Any active ocular surface disease of any severity.
- •Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.
- •Previous corneal surgery in the eye to be treated.
- •Conjunctivochalasis
- •Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.
- •nclusion Criteria: -
- •Exclusion Criteria:
结局指标
主要结局
Uncorrected Distance Visual Acuity (UDVA)
时间窗: Up to 24 months post-treatment
Uncorrected distance visual acuity (UDVA) is to be measured and reported using standard ETDRS visual acuity charts. UDVA change from baseline is also to be reported.
Uncorrected Near Visual Acuity (UNVA)
时间窗: Up to 24 months post-treatment
Uncorrected near visual acuity (UNVA) is to be measured and reported using standard near visual acuity charts. UNVA change from baseline is also to be reported.
次要结局
未报告次要终点
研究者
研究点 (4)
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