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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

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

      • Saint-Étienne, Frankrike, 42055
        • CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur

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:

  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.

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
Övrig: First 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.
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
IMD safety evaluation
Tidsram: 2 hours
To evaluate the IMD safety : Collection of adverse events.
2 hours

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Exploratory evaluation of the IMD - controlled tests assessing visual acuity and performance on visual tasks
Tidsram: 2 hours
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.
2 hours
Exploratory evaluation of the IMD - a questionnaire assessing vision quality
Tidsram: 2 hours
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.
2 hours
Exploratory evaluation of the IMD - patient qualitative feedback
Tidsram: 2 hours
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.
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.

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 .

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