- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05326607
Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia (eve-1)
6 april 2022 uppdaterad av: Laclaree
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Saint-Étienne, Frankrike, 42055
- CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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 Criteria:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: First Arm
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The tested investigational medical device is a prototype of semi-integrated eyeglasses.
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.
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Övrig: Second Arm
|
The tested investigational medical device is a prototype of semi-integrated eyeglasses.
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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IMD safety evaluation
Tidsram: 2 hours
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To evaluate the IMD safety : Collection of adverse events.
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2 hours
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Exploratory evaluation of the IMD - controlled tests assessing visual acuity and performance on visual tasks
Tidsram: 2 hours
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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.
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2 hours
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Exploratory evaluation of the IMD - a questionnaire assessing vision quality
Tidsram: 2 hours
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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.
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2 hours
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Exploratory evaluation of the IMD - patient qualitative feedback
Tidsram: 2 hours
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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.
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2 hours
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Bruno BERGE, PhD, SPONSOR: LACLAREE
- Studierektor: Jessica JAROSZ, PhD, SPONSOR: LACLAREE
- Huvudutredare: Philippe GAIN, Prof., Chu Saint-Etienne
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
- 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)
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
9 september 2021
Primärt slutförande (Faktisk)
27 januari 2022
Avslutad studie (Faktisk)
27 januari 2022
Studieregistreringsdatum
Först inskickad
1 mars 2022
Först inskickad som uppfyllde QC-kriterierna
6 april 2022
Första postat (Faktisk)
13 april 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 april 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 april 2022
Senast verifierad
1 april 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2021-A00521-40
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Not planned
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .