Ocular Adaptation and Visual Performance for Accommodative Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Monocular Refractive Power
研究概览
简要总结
Presbyopes (people who might have a significant loss of their ability to accommodate their crystalline lens in the eye) will be recruited to wear a test lens and perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles.
详细描述
In the proposed study we plan to recruit presbyopes (people who might have a significant loss of their ability to accommodate their crystalline lens in the eye) to wear a test lens and perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles. These are similar to the typical examinations conducted for regular contact lens wearers. Results of this testing will be used to evaluate the efficacy of test lenses and to provide additional information for revision of test lenses. If shown to provide adequate eye comfort and intended vision correction, this lens design has the potential of allowing tens of millions of presbyopes to adapt to contact lenses and significantly improve their vision and well-being.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between 40 and 65 years of age.
- •Have normal/corrected-to-normal monocular acuity of better than 20/25 for both eyes.
- •Have pupil diameter in regular lighting ≥ 2.5 mm.
- •Willing and able to wear multifocal contact lenses in both eyes.
- •Have a current optical prescription (obtained less than 2 years ago).
- •Have spherical equivalent correction equal to or higher than -1.00 Diopter and equal to or less than +0.50 Diopter.
- •Have cylindrical correction equal to less than 0.50 Diopter.
排除标准
- •Have no prismatic correction.
- •Without any eye infection, inflammation, disease, or abnormality that contraindicates contact lens wear within the past 6 months.
- •No clinically significant ocular pathology (e.g., cataract, keratoconus, dry eye, diabetic retinopathy, or age-related macular degeneration)
- •Have no photosensitive disorders, including migraine and seizure.
- •Have no binocular dysfunction, including amblyopia, strabismus, and other binocular diseases.
研究组 & 干预措施
Accommodative contact lens
The accommodative contact lens is composed of traditional hydrogel lens material but has an internal cavity to allow lens deformation that increases its refractive power at an downward angle.
干预措施: Accommodative contact lens (Device)
结局指标
主要结局
Monocular Refractive Power
时间窗: 30 mins of wearing; non-dispensing.
Participants will wear the test lens and look at different downsize angles. The refractive power of the lens/eye combination will be measured with an open-field auto refractor.
Visual Acuity at 20 Degree Downsize Angles
时间窗: 30 mins of wearing; non-dispensing.
The resultant visual acuity at near at this down-gaze angle will be measured. This is achieved by having the subjects holding a new acuity chart at 40 cm distance, their heads upright and perpendicular to the ground, and their gazes rotated downward 20 degrees where the chart was located. The subjects then read out the optotypes (letters) on the chart to a size they cannot no only identify the letters. The lines of letters with which all letters can be identified is recorded as the corresponding level of acuity.
次要结局
未报告次要终点
研究者
Shun-nan Yang
Director of Research at VPI
Pacific University