Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia (eve-1)
2022年4月6日 更新者:Laclaree
Pilot Clinical Investigation of Adaptive Eyeglasses for the Correction of Presbyopia
This study is a pilot clinical investigation of adaptive eyeglasses for the correction of presbyopia.
The goal of this clinical investigation is to assess IMD safety and to obtain patient feedback on the usefulness of the Laclarée eyeglasses, through subjective clinical measures and qualitative evaluations.
This is an exploratory investigation.
研究概览
详细说明
Presbyopia is a visual impairment caused by the normal aging of the eye lens and resulting in progressive loss of accommodation.
As a consequence, from the onset of presbyopia occurring around 40-45 years old, the eye has growing trouble focusing at near and intermediate distances.
Millions of presbyopes encounter difficulties with current corrective solutions, leading to vision and postural discomfort.
Laclarée's adaptive eyeglasses are providing an alternative solution, closer to the native crystalline accommodation.
Besides an enhanced field-of-view, these eyeglasses offer a disruptive ergonomics where the glasses automatically adjust to the wearer's need to provide clear vision at all distances and can be electronically recalibrated to adjust the delivered addition throughout presbyopia.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Saint-Étienne、法国、42055
- CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patient >18 years of age, male or female who has given explicit informed consent (dated and signed)
- Diagnosed with presbyopia
- A wearer whose current corrective solution is a pair of progressive lenses that provide clear vision at both distance and near vision (worn at least 5 times per week for 4 hours per day), or, a wearer who has rejected progressive glasses that provide clear vision at both distance and near vision and who uses another corrective solution that provides clear vision at both distance and near vision (bifocal glasses, multifocal or monovision lenses, multiple pairs of glasses or one pair for cases of emmetropia)
- Patient with a distance visual acuity of 10/10 at least with current corrective solution
- Patient with a visual acuity of P2 at least in near vision with current corrective solution
- Patient with at least 10/10 distance vision once corrected with contact lenses for the test
- Inter-pupillary distance in distance vision between 55 and 71mm
- Distance from temple-to-temple not exceeding 161mm
- Addition greater than or equal to 1.75D: Add≥1.75D
- Sphere strictly between -6D and +4D: -6D<S<+4D
- Cylinder below 1.75D:C<1.75D
- Patient uses a computer (at least 3 times a week in private and/or work settings).
- Affiliation to a social security scheme
- French-speaking (fluent).
- Patient willing to participate in the study.
Exclusion Criteria:
- Patient under tutorship or guardianship.
- Patient unable to understand the study procedures and therefore to provide free and informed consent
- Patient with reading difficulties
- Patient with multifocal implants
- Patient who has undergone multifocal surgery
- Patient with prism correction
- Patient with a current or past eye condition that may adversely affect vision
- Patient being treated or having undergone surgery likely to adversely affect vision
- Patient with mobility problems that would prevent tests and workshops from being carried out
- Patient intolerant to wearing contact lenses for a few hours (only for presbyopes with ametropia)
- Patient who is pregnant or breastfeeding
- Patient already included once in the study
- Patient placed in an institution based on a judicial or regulatory ruling, held in psychiatric department, in state-run prison, or employed by the study research sites or by the sponsor.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:First Arm
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The tested investigational medical device is a prototype of semi-integrated eyeglasses.
The comparator is either a pair of progressive lenses that provide clear vision at both distance and near vision, either, for wearers who have rejected progressive glasses, an alternative solution providing clear vision at both distance and near vision which can consist of bifocal glasses, multifocal or monovision lenses, multiple pairs of glasses or one pair for cases of emmetropia.
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其他:Second Arm
|
The tested investigational medical device is a prototype of semi-integrated eyeglasses.
The comparator is either a pair of progressive lenses that provide clear vision at both distance and near vision, either, for wearers who have rejected progressive glasses, an alternative solution providing clear vision at both distance and near vision which can consist of bifocal glasses, multifocal or monovision lenses, multiple pairs of glasses or one pair for cases of emmetropia.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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IMD safety evaluation
大体时间:2 hours
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To evaluate the IMD safety : Collection of adverse events.
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2 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Exploratory evaluation of the IMD - controlled tests assessing visual acuity and performance on visual tasks
大体时间:2 hours
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To make an exploratory evaluation of the IMD performance on patient vision quality, when compared to that obtained with the patient usual personal eyewear (comparator) : Subjective measures on controlled tests assessing visual acuity and performance on visual tasks.
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2 hours
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Exploratory evaluation of the IMD - a questionnaire assessing vision quality
大体时间:2 hours
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To make an exploratory evaluation of the IMD performance on patient vision quality, when compared to that obtained with the patient usual personal eyewear (comparator) : Subjective measures on questionnaires.
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2 hours
|
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Exploratory evaluation of the IMD - patient qualitative feedback
大体时间:2 hours
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To make an exploratory evaluation of the IMD performance on patient vision quality, when compared to that obtained with the patient usual personal eyewear (comparator) : Collection of patient feedback.
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2 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
合作者
调查人员
- 学习椅:Bruno BERGE, PhD、SPONSOR: LACLAREE
- 研究主任:Jessica JAROSZ, PhD、SPONSOR: LACLAREE
- 首席研究员:Philippe GAIN, Prof.、Chu Saint-Etienne
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
- Jessica Jarosz, Norbert Molliex, Guilhem Chenon, and Bruno Berge, "Adaptive eyeglasses for presbyopia correction: an original variable-focus technology," Opt. Express 27, 10533-10552 (2019)
- Jessica Jarosz, Norbert Molliex, Quentin Lavigne, and Bruno Berge "An original low-power opto-fluidic engine for presbyopia-correcting adaptive eyeglasses", Proc. SPIE 10858, Ophthalmic Technologies XXIX, 1085824 (28 February 2019)
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年9月9日
初级完成 (实际的)
2022年1月27日
研究完成 (实际的)
2022年1月27日
研究注册日期
首次提交
2022年3月1日
首先提交符合 QC 标准的
2022年4月6日
首次发布 (实际的)
2022年4月13日
研究记录更新
最后更新发布 (实际的)
2022年4月13日
上次提交的符合 QC 标准的更新
2022年4月6日
最后验证
2022年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.