NCT05036954Unknown不适用
Observational Study on the Efficacy and Tolerance of EYEBRID Lenses
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- tolerance assesment
研究概览
简要总结
Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities.
This study should include 60 patients for a period of three months. The aim of this work is to assess the improvement in the best corrected visual acuity and the good tolerance of this lens.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o Wear rigid lenses and complain about their lenses (discomfort, loss, poor vision) or
- •Wear rigid lenses and have objective intolerances (damage to surfaces related to rigid lenses) or
- •Are new wearers of lenses and presenting a strong ametropia (Strong myopia from -5.00 to -30.00d, strong hyperopia from + 4.50d to + 30.00d, strong astigmatism from 2.50d to 12.00d), with or without presbyopia (Addition of 0.75d to 3.50d)
- •Any patient diagnosed with Keratoconus stages 1 to
- •Be affiliated to the social security system
排除标准
- •Patient with contraindications to wearing contact lenses
- •Pregnant or breastfeeding woman
- •Any minor or over 80 years old
- •Any infection, inflammation or abnormality of the anterior segments
- •Progressive ocular disorder of the anterior segments for which the wearing of contact lenses would be discouraged;
- •Use of systemic or ocular treatment products for which the wearing of contact lenses would be discouraged;
- •History of any herpetic keratitis;
- •History of any refractive surgery or any irregular cornea (except in cases where the contact lenses examined may be worn by a subject with an irregular cornea, suffering from keratoconus or having undergone refractive surgery);
- •Slit lamp observations of greater than grade 1 gravity;
- •Vascularization of the cornea with a penetration greater than 1 mm;
- •Case of pathological dry eye;
- •When a subject has participated in a clinical trial on contact lenses or contact lens care products within the past 30 days.
结局指标
主要结局
tolerance assesment
时间窗: 3 month
scale of discomfort when using contact lenses
次要结局
- Assessment and quantification of complications(3 month)
- Improvement of visual acuity(3 month)
研究者
研究点 (1)
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