Post Market Clinical Study to Compare Vision With Essilor® AVA™ Lenses Following AVA™ Refraction Protocol to Equivalent Lenses Following Gold Standard Refraction Protocol.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Vision correction preference
研究概览
简要总结
The goal of this clinical trial is to assess improvements in visual performance and patient outcomes in wearing new spectacle lenses in general population.
The two spectacle lenses will be compared after two weeks of wearing.
The aims are:
- to evaluate the visual superiority, and quality-of-life implications of Essilor® AVA™ spectacle lenses prescribed after a new subjective refraction protocol named AVA™ protocol.
- to understand the benefits of using a high accuracy instrument and testing sequence over the standard testing sequence in determining a glasses prescription, as well as the overall subjective performance of the resulting glasses.
详细描述
This study aims to evaluate whether finer increments in refraction and spectacle lens manufacturing (0.01D) provide more precise visual corrections compared to the traditional 0.25D steps, and if participants can visually appreciate this difference in the refractive outcome and manufactured lenses. It will assess improvements in visual acuity, comfort, and patient satisfaction, focusing on achieving red-green equality in the duo chrome test and exploring the clinical utility of higher resolution refraction technologies.
Refraction is a critical procedure in eye care that determines the optimal lens power for a focused retinal image. Traditional manual phoropters, the standard for over a century, operate in 0.25D increments but have limitations, as most individuals are sensitive to smaller power variations. Recent technological advancements, such as digital phoropters like the Vision-R™ 800, allow for continuous power adjustments in increments as fine as 0.01D and support manufacturing spectacles in smaller steps.
While these innovations offer theoretical advantages, their clinical impact remains relatively underexplored. This study addresses this gap by comparing traditional and finer increment prescriptions to assess improvements in visual performance and patient outcomes. Results could redefine refraction standards and optimize optometric care practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 y/o and 70
- •Accepted and signed the consent form
- •Agree to participate in the scheduled visits
- •Best-corrected visual acuity by manifest refraction of +0.10 log MAR (20/25 Snellen) or better in each eye
- •Spherical Equivalent Refractive Error between -10.00 and 10.00 D
- •Possess current wearable and visually functional eyeglasses
- •Agree to wear the assigned frames fitted with the provided lenses for a minimum of 14 days, during 6h/day, equivalent to 42 hours of wearing a week.
- •No binocular vision issues
- •No cataract, grade 2 or greater
- •Presbyope subjects: To be eligible for the presbyopic group, individuals need to be (half of the analyzed population):
- •35-70 years of age, inclusive
- •Currently wearing and adapted to progressive addition lenses
排除标准
- •Less than 18 years or greater than 70 years of age
- •Does not wear spectacles at least 6 hours/day
- •Does not have a wearable pair of glasses with a prescription ≤2 years old
- •Currently or formerly a licensed optometrist, optician, or ophthalmic technician trained in refraction
研究组 & 干预措施
First Essilor® AVA™ and then Standard
Participants are first prescribed for AVA™ protocol and then for Standard protocol . Patients will first wear the Essilor® AVA™ lenses during 2 weeks. Then, after a washout period of 2 weeks, patients will wear the Standard lenses during 2 weeks.
干预措施: AVA lenses (Device)
First Essilor® AVA™ and then Standard
Participants are first prescribed for AVA™ protocol and then for Standard protocol . Patients will first wear the Essilor® AVA™ lenses during 2 weeks. Then, after a washout period of 2 weeks, patients will wear the Standard lenses during 2 weeks.
干预措施: Standard lenses (Device)
First Standard then Essilor® AVA™
Participants are first prescribed for Standard protocol and then for AVA™ protocol . Patients will first wear the Standard lenses during 2 weeks. Then, after a washout period of 2 weeks, patients will wear the Essilor® AVA™ lenses during 2 weeks.
干预措施: AVA lenses (Device)
First Standard then Essilor® AVA™
Participants are first prescribed for Standard protocol and then for AVA™ protocol . Patients will first wear the Standard lenses during 2 weeks. Then, after a washout period of 2 weeks, patients will wear the Essilor® AVA™ lenses during 2 weeks.
干预措施: Standard lenses (Device)
结局指标
主要结局
Vision correction preference
时间窗: through study completion, an average of 8 weeks
Proportion of subjects preferring vision correction option between Essilor® AVA™ lenses and the alternative vision correction solution
次要结局
- Subjective Binocular Vision Quality(immediately after the intervention, and through study completion, an average of 8 weeks)
- Subjective Binocular Vision(immediately after the intervention, and through study completion, an average of 8 weeks)
- Accuracy of refraction(immediately after the intervention, and through study completion, an average of 8 weeks.)
- accuracy of refraction(immediately after the intervention, and through study completion, an average of 8 weeks.)
- perceived refraction experience(immediately after the intervention)
- Refraction experience accuracy of refraction(through study completion, an average of 8 weeks.)
- Subjective refraction experience(immediately after intervention)
- Subjective Vision Quality with Essilor® AVA™ lenses(immediately after intervention, through study completion, an average of 8 weeks.)
- Binocular high-contrast, high-illumination logMAR distance visual acuity(immediately after intervention, through completion of study, an average of 8 weeks.)
- binocular high-contrast high-illumination distance visual acuity(immediately after intervention, through completion of study, an average of 8 weeks.)
- Binocular low-contrast high-illumination distance logMAR visual acuity(immediately after intervention, through completion of study, an average of 8 weeks.)
- binocular low-contrast high-illumination distance log MAR visual acuity(immediately after intervention, through completion of study, an average of 8 weeks.)
- Binocular low-contrast low-illumination distance logMAR visual acuity(immediately after intervention, through completion of study, an average of 8 weeks.)
- Duochrome Equality(immediately after intervention)
- relative frequency of Duochrome Equality(through study completion, an average of 8 weeks.)
- scores assessing lenses evaluated by Patient (Preference)(through study completion, an average of 8 weeks.)
- binocular stereo acuity(immediately after intervention)
- Binocular distance contrast sensitivity(immediately after intervention, through completion of study, an average of 8 weeks.)
- binocular low-contrast low-illumination distance log MAR visual acuity(immediately after intervention, through completion of study, an average of 8 weeks.)
- 5-point Likert(through study completion, an average of 8 weeks.)
- relative frequencies of scores(through study completion, an average of 8 weeks.)
- scores assessing lenses in Subjective Vision Quality(through study completion, an average of 8 weeks.)