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

Primary Purpose

Presbyopia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Prototype of adaptive eyeglasses

Comparator

About this trial

This is an interventional supportive care trial for Presbyopia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

First Arm

Second Arm

Arm Description

Outcomes

Primary Outcome Measures

IMD safety evaluation

To evaluate the IMD safety : Collection of adverse events.

Secondary Outcome Measures

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.

Exploratory evaluation of the IMD - a questionnaire assessing vision quality

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.

Full Information

NCT ID

NCT05326607

First Posted

March 1, 2022

Last Updated

April 6, 2022

Sponsor

Laclaree

Collaborators

Iris Pharma

1. Study Identification

Unique Protocol Identification Number

NCT05326607

Brief Title

Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia

Acronym

eve-1

Official Title

Pilot Clinical Investigation of Adaptive Eyeglasses for the Correction of Presbyopia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

September 9, 2021 (Actual)

Primary Completion Date

January 27, 2022 (Actual)

Study Completion Date

January 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laclaree

Collaborators

Iris Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Presbyopia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

First Arm

Arm Type

Other

Arm Title

Second Arm

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Prototype of adaptive eyeglasses

Intervention Description

The tested investigational medical device is a prototype of semi-integrated eyeglasses.

Intervention Type

Device

Intervention Name(s)

Comparator

Intervention Description

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.

Primary Outcome Measure Information:

Title

IMD safety evaluation

Description

To evaluate the IMD safety : Collection of adverse events.

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

Exploratory evaluation of the IMD - controlled tests assessing visual acuity and performance on visual tasks

Description

Time Frame

2 hours

Title

Exploratory evaluation of the IMD - a questionnaire assessing vision quality

Description

Time Frame

2 hours

Title

Exploratory evaluation of the IMD - patient qualitative feedback

Description

Time Frame

2 hours

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruno BERGE, PhD

Organizational Affiliation

SPONSOR: LACLAREE

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jessica JAROSZ, PhD

Organizational Affiliation

SPONSOR: LACLAREE

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Philippe GAIN, Prof.

Organizational Affiliation

CHU SAINT-ETIENNE

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur

City

Saint-Étienne

ZIP/Postal Code

42055

Country

France

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Not planned

Links:

URL

https://opg.optica.org/oe/fulltext.cfm?uri=oe-27-8-10533&id=408132

Description

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)

URL

https://doi.org/10.1117/12.2507816

Description

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)

Learn more about this trial

Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia

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