Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia (eve-1)

L

Laclaree

Status

Completed

Conditions

Presbyopia

Treatments

Device: Prototype of adaptive eyeglasses
Device: Comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT05326607
2021-A00521-40

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patient >18 years of age, male or female who has given explicit informed consent (dated and signed)
  2. Diagnosed with presbyopia
  3. 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)
  4. Patient with a distance visual acuity of 10/10 at least with current corrective solution
  5. Patient with a visual acuity of P2 at least in near vision with current corrective solution
  6. Patient with at least 10/10 distance vision once corrected with contact lenses for the test
  7. Inter-pupillary distance in distance vision between 55 and 71mm
  8. Distance from temple-to-temple not exceeding 161mm
  9. Addition greater than or equal to 1.75D: Add≥1.75D
  10. Sphere strictly between -6D and +4D: -6D<S<+4D
  11. Cylinder below 1.75D:C<1.75D
  12. Patient uses a computer (at least 3 times a week in private and/or work settings).
  13. Affiliation to a social security scheme
  14. French-speaking (fluent).
  15. Patient willing to participate in the study.

Exclusion criteria

  1. Patient under tutorship or guardianship.
  2. Patient unable to understand the study procedures and therefore to provide free and informed consent
  3. Patient with reading difficulties
  4. Patient with multifocal implants
  5. Patient who has undergone multifocal surgery
  6. Patient with prism correction
  7. Patient with a current or past eye condition that may adversely affect vision
  8. Patient being treated or having undergone surgery likely to adversely affect vision
  9. Patient with mobility problems that would prevent tests and workshops from being carried out
  10. Patient intolerant to wearing contact lenses for a few hours (only for presbyopes with ametropia)
  11. Patient who is pregnant or breastfeeding
  12. Patient already included once in the study
  13. 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

First Arm
Other group
Treatment:
Device: Comparator
Device: Prototype of adaptive eyeglasses
Second Arm
Other group
Treatment:
Device: Comparator
Device: Prototype of adaptive eyeglasses

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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