Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia

Presbyopia Clinical Trial

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Official title:

Pilot Clinical Investigation of Adaptive Eyeglasses for the Correction of Presbyopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326607
• Other study ID #: 2021-A00521-40
• Status: Completed
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: January 27, 2022

Study information

• Verified date: April 2022
• Source: Laclaree
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Prototype of adaptive eyeglasses
The tested investigational medical device is a prototype of semi-integrated eyeglasses.
• 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.

Locations

Country	Name	City	State
France	CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Laclaree	Iris Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IMD safety evaluation	To evaluate the IMD safety : Collection of adverse events.	2 hours
Secondary	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
Secondary	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
Secondary	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

External Links

•   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)
•   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)