Clinical trial NCT05326607: Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia
Official title: Pilot Clinical Investigation of Adaptive Eyeglasses for the Correction of Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Laclaree
Sponsor class: INDUSTRY
Collaborators: name: Iris Pharma
First posted: 2022-04-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IMD safety evaluation
timeFrame: 2 hours
Secondary outcomes:
measure: Exploratory evaluation of the IMD - controlled tests assessing visual acuity and performance on visual tasks
timeFrame: 2 hours
measure: Exploratory evaluation of the IMD - a questionnaire assessing vision quality
timeFrame: 2 hours
measure: Exploratory evaluation of the IMD - patient qualitative feedback
timeFrame: 2 hours
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur
Study officials:
affiliation: SPONSOR: LACLAREE
name: Bruno BERGE, PhD
role: STUDY_CHAIR
affiliation: SPONSOR: LACLAREE
name: Jessica JAROSZ, PhD
role: STUDY_DIRECTOR
affiliation: CHU SAINT-ETIENNE
name: Philippe GAIN, Prof.
role: PRINCIPAL_INVESTIGATOR
References: