Presbyopiaeve-1NCT05326607
Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia
A study testing Prototype of adaptive eyeglasses and Comparator in people with Presbyopia, run by Laclaree at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Presbyopia
- What is being tested?
- Prototype of adaptive eyeglasses and Comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2021to 27 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur
Saint-Etienne, 42055
About this study
Official title: Pilot Clinical Investigation of Adaptive Eyeglasses for the Correction of Presbyopia
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.
Read the 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.
- Conditions
- Presbyopia
- Being tested
- Prototype of adaptive eyeglasses, Comparator
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype of adaptive eyeglassesDevice
The tested investigational medical device is a prototype of semi-integrated eyeglasses.
ComparatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| First Arm | Other | Not described Receives: Device: Prototype of adaptive eyeglasses; Device: Comparator |
| Second Arm | Other | Not described Receives: Device: Prototype of adaptive eyeglasses; Device: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMD safety evaluation
To evaluate the IMD safety : Collection of adverse events.
Measured: 2 hours
Secondary outcomes (3)
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.
Measured: 2 hours
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.
Measured: 2 hours
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start9 Sep 2021
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laclaree
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Iris Pharma
- Responsible party
- Sponsor
- Investigators
- Bruno BERGE, PhD, Study chair, SPONSOR: LACLAREEJessica JAROSZ, PhD, Study director, SPONSOR: LACLAREEPhilippe GAIN, Prof., Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326607
- Sponsor's protocol ID
- 2021-A00521-40
- Acronym
- eve-1
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Investigation of Adaptive Eyeglasses for the Correction of Presbyopia
- ClinicalTrials.gov ID
- NCT05326607
- Acronym / sponsor ID
- eve-1 / 2021-A00521-40
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LaclareeIndustry (pharma, biotech, devices)
- Collaborators
- Iris Pharma
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Arm | Other | Device: Prototype of adaptive eyeglasses, Device: Comparator |
| Second Arm | Other | Device: Prototype of adaptive eyeglasses, Device: Comparator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype of adaptive eyeglassesThe tested investigational medical device is a prototype of semi-integrated eyeglasses. | Device | First Arm, Second Arm |
| ComparatorThe 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. | Device | First Arm, Second Arm |
Primary outcome
IMD safety evaluation
Time frame: 2 hours
To evaluate the IMD safety : Collection of adverse events.
3 secondary outcomes
Exploratory evaluation of the IMD - controlled tests assessing visual acuity and performance on visual tasks
Time frame: 2 hours
Exploratory evaluation of the IMD - a questionnaire assessing vision quality
Time frame: 2 hours
Exploratory evaluation of the IMD - patient qualitative feedback
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- 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)Link provided by the sponsor.
- 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)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Not planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno BERGE, PhD study chair
SPONSOR: LACLAREE
Jessica JAROSZ, PhD study director
SPONSOR: LACLAREE
Philippe GAIN, Prof. principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype of adaptive eyeglasses and Comparator in people with Presbyopia, run by Laclaree at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMD safety evaluation (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.