Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle (CZV_PAL1)

17. april 2017 oppdatert av: Meng C. Lin, University of California, Berkeley
The purpose of this study was to compare objective clinical measures of visual performance and subjective measures of satisfaction and preference between standard progressive addition lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL spectacle.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

In a double-masked crossover trial, 95 experienced wearers wore customized free-form PAL spectacles (Test) and standard non-free-form PAL spectacles (Control) for one week each. All subjects wore both Test and Control spectacles, and the pair to be worn first was randomly assigned. At dispensing and after 1 week of wear, subjects were tested for distance and near visual acuity (VA) under both high and low contrast; in addition, 30 degree off-axis VA was measured using a novel apparatus, as was the horizontal extent of undistorted vision at reading distance. Subjects also completed a set of questionnaires detailing their satisfaction levels, adaptation times, and preferences for Test or Control spectacles for different visual tasks.

Studietype

Intervensjonell

Registrering (Faktiske)

95

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Berkeley, California, Forente stater, 94720-2020
        • Clinical Research Center, School of Optometry, University of California, Berkeley

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

39 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Presbyope
  • Experienced PAL spectacle wearer
  • Correctable to at least 20/25 in both eyes
  • Able and willing to use Test and Control spectacles for 1 week each as primary form of presbyopia correction
  • Able and willing to complete all laboratory measurements and questionnaire batteries

Exclusion Criteria:

  • Purchasing free-form PAL spectacles from the UC Berkeley Eyewear Center
  • Having eye conditions or diseases that could potentially cause a decrease in visual acuity over the course of participation in the study
  • Having eye conditions or diseases that could potentially interfere with ability to use Test and Control spectacles as primary form of presbyopia correction

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Randomized Order of Interventions 1
Randomized to first wear standard, non-free-form, non-customized PAL spectacles, then second, crossover to wear individually customized free-form surfaced PAL spectacles
Enhet: Standard, non-free-form, non-customized PAL spectacles
Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.
Enhet: Individually customized free-form surfaced PAL spectacles
Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
Andre navn:
  • Zeiss Individual, Carl Zeiss Vision, Inc., Germany
Aktiv komparator: Randomized Order of Interventions 2
Randomized to first wear individually customized free-form surfaced PAL spectacles, then second, crossover to wear standard, non-free-form, non-customized PAL spectacles
Enhet: Standard, non-free-form, non-customized PAL spectacles
Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.
Enhet: Individually customized free-form surfaced PAL spectacles
Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
Andre navn:
  • Zeiss Individual, Carl Zeiss Vision, Inc., Germany

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual Acuity, High Contrast, Distance Chart
Tidsramme: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Visual Acuity, Low Contrast, Distance Chart
Tidsramme: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Visual Acuity, High Contrast, Near Chart
Tidsramme: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Visual Acuity, Low Contrast, Near Chart
Tidsramme: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
30-degree Off-axis Distance Visual Acuity, High Contrast Chart
Tidsramme: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
30-degree Off-axis Distance Visual Acuity, Low Contrast Chart
Tidsramme: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Horizontal Extent of Undistorted Vision at Reading Distance
Tidsramme: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Questionnaire Battery
Tidsramme: At study exit, after both Test and Control spectacles had been worn for 1 week each
Forced-choice Likert scale preference questionnaire
At study exit, after both Test and Control spectacles had been worn for 1 week each

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, Berkeley

Samarbeidspartnere

Carl Zeiss Meditec, Inc.

Etterforskere

  • Hovedetterforsker: Meng C. Lin, OD, PhD, Clinical Research Center, School of Optometry, University of California, Berkeley

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2009

Primær fullføring (Faktiske)

1. oktober 2009

Studiet fullført (Faktiske)

1. oktober 2009

Datoer for studieregistrering

Først innsendt

3. november 2010

Først innsendt som oppfylte QC-kriteriene

3. november 2010

Først lagt ut (Anslag)

4. november 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CZV_PAL1

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Presbyopi

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Bosnia & Herzegovina

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere