Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Clinical Investigation of Adaptive Eyeglasses for the Correction of Presbyopia

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Prototype of adaptive eyeglasses
* Device: Comparator


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: First Arm<br> | Device: Prototype of adaptive eyeglasses<br>* The tested investigational medical device is a prototype of semi-integrated eyeglasses.<br>Device: Comparator<br>* 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.<br>|
| Other: Second Arm<br> | Device: Prototype of adaptive eyeglasses<br>* The tested investigational medical device is a prototype of semi-integrated eyeglasses.<br>Device: Comparator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMD safety evaluation | To evaluate the IMD safety : Collection of adverse events. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory evaluation of the IMD - controlled tests assessing visual acuity and performance on visual tasks | 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. | 2 hours | 
| Exploratory evaluation of the IMD - a questionnaire assessing vision quality | 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. | 2 hours | 
| Exploratory evaluation of the IMD - patient qualitative feedback | 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. | 2 hours |