Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia

NCT05326607 | Completed

• 1 other identifier: 2021-A00521-40
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• IMD safety evaluation

  To evaluate the IMD safety : Collection of adverse events.

  2 hours

Secondary Outcomes (3)

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

  2 hours

• Exploratory evaluation of the IMD - a questionnaire assessing vision quality

  2 hours

• Exploratory evaluation of the IMD - patient qualitative feedback

  2 hours

Study Arms (2)

First Arm

OTHER

Device: Prototype of adaptive eyeglasses; Device: Comparator

Second Arm

OTHER

Device: Prototype of adaptive eyeglasses; Device: Comparator

Interventions

Prototype of adaptive eyeglasses DEVICE

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

First Arm; Second Arm

Comparator DEVICE

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.

First Arm; Second Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laclaree: lead
• Iris Pharma: collaborator

Study Sites (1)

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

Saint-Etienne, 42055, France

Location

Related 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)

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Bruno BERGE, PhD

  SPONSOR: LACLAREE

  STUDY CHAIR

• Jessica JAROSZ, PhD

  SPONSOR: LACLAREE

  STUDY DIRECTOR

• Philippe GAIN, Prof.

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: April 13, 2022
• Study Start: September 9, 2021
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)