A Feasibility Study to Assess the Visual Performance and Comfort of Hanita G4 Multifocal Soft Contact Lenses for Presbyopia at Normal Daily Routine Use.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Assess visual acuity
研究概览
简要总结
The G4 Multi multifocal contact lens is a soft contact lens intended to correct far, intermediate, and near vision for individuals with presbyopia. The lens covers the cornea and part of the sclera. The lenses can be used for daily wear for up to 1 year.
详细描述
Study Design:
A clinical performance study without a control group to compare the G4Multi contact lens to other approved soft contact lenses for presbyopia
Study Objectives:
- To assess the multifocal vision in the various ranges of the HANITA G4 Multi.
- To rate the comfort of the lenses in individuals with presbyopia
Study population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presbyopia participants with healthy eyes who are not using any ocular medications, aged 18 years and over and who have used contact lenses in the past
- •Lens powers within the range available for the test lenses
- •Best spectacle-corrected visual acuity equal or greater than 20/25 (less than or equal to Log MAR 0.1)
排除标准
- •Anterior segment infection, inflammation, or abnormality
- •Any active anterior segment ocular disease that would contraindicate contact lens wear
- •The use of systemic or ocular medications that would contraindicate contact lens wear
- •History of herpetic keratitis
- •History of refractive surgery or irregular cornea
- •Slit lamp findings that are more serious than grade 1
- •Corneal vascularization greater than 1 mm of penetration
- •Pathologically dry eye;
- •Participation in a contact lens or contact lens care product clinical trial within the previous 30 days
结局指标
主要结局
Assess visual acuity
时间窗: 11-12 months
Distance (far) manifest refraction and the testing distance used will be recorded on the case report forms. Manifest refraction will be determined using the maximum plus for best visual acuity method. The distance manifest refraction will be measured with a distance adjusted chart but not less than 4 meters. The actual manifest refraction distance will be noted on the case report forms. Results will be recorded in a Log Mar scale.
次要结局
- Assess subjective degree of comfort while wearing the lenses(11-12 months)
- SLIT LAMP EXAM(11-12 months)