NCT05326607

Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia

Pilot Clinical Investigation of Adaptive Eyeglasses for the Correction of Presbyopia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Laclaree · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Prototype of adaptive eyeglasses	The tested investigational medical device is a prototype of semi-integrated eyeglasses.
DEVICE	Comparator	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.

Timeline

• Start date: 2021-09-09
• Primary completion: 2022-01-27
• Completion: 2022-01-27
• First posted: 2022-04-13
• Last updated: 2022-04-13

Locations

1 site across 1 country: France