Status:
COMPLETED
Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia
Lead Sponsor:
Laclaree
Collaborating Sponsors:
Iris Pharma
Conditions:
Presbyopia
Eligibility:
All Genders
Phase:
NA
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 ...
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 y...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05326607
Start Date
September 9 2021
End Date
January 27 2022
Last Update
April 13 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur
Saint-Etienne, France, 42055