Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Visual Acuity, Low Contrast, Distance Chart
研究概览
简要总结
The purpose of this study was to compare objective clinical measures of visual performance and subjective measures of satisfaction and preference between standard progressive addition lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL spectacle.
详细描述
In a double-masked crossover trial, 95 experienced wearers wore customized free-form PAL spectacles (Test) and standard non-free-form PAL spectacles (Control) for one week each. All subjects wore both Test and Control spectacles, and the pair to be worn first was randomly assigned. At dispensing and after 1 week of wear, subjects were tested for distance and near visual acuity (VA) under both high and low contrast; in addition, 30 degree off-axis VA was measured using a novel apparatus, as was the horizontal extent of undistorted vision at reading distance. Subjects also completed a set of questionnaires detailing their satisfaction levels, adaptation times, and preferences for Test or Control spectacles for different visual tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 39 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presbyope
- •Experienced PAL spectacle wearer
- •Correctable to at least 20/25 in both eyes
- •Able and willing to use Test and Control spectacles for 1 week each as primary form of presbyopia correction
- •Able and willing to complete all laboratory measurements and questionnaire batteries
排除标准
- •Purchasing free-form PAL spectacles from the UC Berkeley Eyewear Center
- •Having eye conditions or diseases that could potentially cause a decrease in visual acuity over the course of participation in the study
- •Having eye conditions or diseases that could potentially interfere with ability to use Test and Control spectacles as primary form of presbyopia correction
结局指标
主要结局
Visual Acuity, Low Contrast, Distance Chart
时间窗: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M\&S Technologies Smart System II visual acuity projection system.
Questionnaire Battery
时间窗: At study exit, after both Test and Control spectacles had been worn for 1 week each
Forced-choice Likert scale preference questionnaire
Horizontal Extent of Undistorted Vision at Reading Distance
时间窗: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid
Visual Acuity, High Contrast, Distance Chart
时间窗: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M\&S Technologies Smart System II visual acuity projection system.
Visual Acuity, High Contrast, Near Chart
时间窗: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M\&S Technologies Smart System II visual acuity projection system.
Visual Acuity, Low Contrast, Near Chart
时间窗: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M\&S Technologies Smart System II visual acuity projection system.
30-degree Off-axis Distance Visual Acuity, Low Contrast Chart
时间窗: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
30-degree Off-axis Distance Visual Acuity, High Contrast Chart
时间窗: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
次要结局
未报告次要终点
研究者
Meng C. Lin
Director, Clinical Research Center
University of California, Berkeley