NCT04883099已完成不适用
7 Day Trial of APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Visual Acuity Intermediate
研究概览
简要总结
Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism contact lenses.
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
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must provide written informed consent.
- •The subject must appear willing and able to adhere to the instructions set forth in this protocol.
- •At least 40 years of age and no more than 70 years of age.
- •≤ 4.00 D of corneal astigmatism.
- •≤ 2.50 D of refractive astigmatism.
- •Refractive error range +4.00 DS to -6.00 DS
- •Require a reading addition (bifocal) of at least 0.75 D
- •Flat and steep keratometry readings within 40 to 48 D.
- •Clear, healthy corneas with no irregular astigmatism.
- •Normal, healthy conjunctiva in both eyes.
- •Free of active ocular disease. Refractive error and presbyopia are permitted.
- •Be a current or former (within the last 3 years) contact lens wearer.
- •Best-corrected near and distance visual acuity better than or equal to 20/25.
排除标准
- •Irregular corneal astigmatism.
- •Corneal scarring unless off line-of-site and well healed.
- •Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
- •Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Occasional artificial tear use is permitted.
- •Systemic disease that would interfere with contact lens wear.
- •Currently pregnant or lactating (by self-report).
- •History of strabismus or eye movement disorder, including exophoria at near that is 4 D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.
- •Active allergies that may inhibit contact lens wear.
- •Upper eyelid margin at or above the superior limbus.
- •History of ocular or lid surgery.
- •Immediate family members or significant others of doctors or staff at the clinical site.
研究组 & 干预措施
APIOC for Presbyopia and Presbyopia with Astigmatism
Experimental
Presbyopic Spherical or Toric Contact Lens
干预措施: APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism (Device)
结局指标
主要结局
Visual Acuity Intermediate
时间窗: Day 7
High and Low Contrast
Visual Acuity Distance
时间窗: Day 7
High and Low Contrast LogMAR
Subjective Vision Quality
时间窗: Day 7
Visual analogue scale (0-100 points) 100 is best possible quality of vision
Comfort
时间窗: Day 7
Visual analogue scale(0-100 points) 100 is best possible comfort
Visual Acuity Near
时间窗: Day 7
High and Low Contrast
次要结局
- Subjective vision Comparison(Day 7)
- Subjective Comfort(Day 7)
研究者
研究点 (6)
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