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| Name | Class |
|---|---|
| Iris Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Arm | Other |
| |
| Second Arm | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype of adaptive eyeglasses | Device | The tested investigational medical device is a prototype of semi-integrated eyeglasses. |
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| Measure | Description | Time Frame |
|---|---|---|
| IMD safety evaluation | To evaluate the IMD safety : Collection of adverse events. | 2 hours |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno BERGE, PhD | SPONSOR: LACLAREE | Study Chair |
| Jessica JAROSZ, PhD | SPONSOR: LACLAREE | Study Director |
| Philippe GAIN, Prof. | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur | Saint-Etienne | 42055 | France |
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| Label | URL |
|---|---|
| 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) | View source |
| 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) | View source |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Comparator | Device | 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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| 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 |