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

Sponsor
Laclaree (Industry)
Overall Status
Completed
CT.gov ID
NCT05326607
Collaborator
Iris Pharma (Industry)
40
1
2
4.6
8.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Prototype of adaptive eyeglasses
  • Device: Comparator
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Pilot Clinical Investigation of Adaptive Eyeglasses for the Correction of Presbyopia
Actual Study Start Date :
Sep 9, 2021
Actual Primary Completion Date :
Jan 27, 2022
Actual Study Completion Date :
Jan 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: First Arm

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.

Other: Second Arm

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.

Outcome Measures

Primary Outcome Measures

  1. IMD safety evaluation [2 hours]

    To evaluate the IMD safety : Collection of adverse events.

Secondary Outcome Measures

  1. Exploratory evaluation of the IMD - controlled tests assessing visual acuity and performance on visual tasks [2 hours]

    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. Exploratory evaluation of the IMD - a questionnaire assessing vision quality [2 hours]

    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.

  3. Exploratory evaluation of the IMD - patient qualitative feedback [2 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur Saint-Étienne France 42055

Sponsors and Collaborators

  • Laclaree
  • Iris Pharma

Investigators

  • Study Chair: Bruno BERGE, PhD, SPONSOR: LACLAREE
  • Study Director: Jessica JAROSZ, PhD, SPONSOR: LACLAREE
  • Principal Investigator: Philippe GAIN, Prof., CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Laclaree
ClinicalTrials.gov Identifier:
NCT05326607
Other Study ID Numbers:
  • 2021-A00521-40
First Posted:
Apr 13, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022