Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Evaluating and Improving Functional Driving Vision of Patients With Astigmatism

24. februar 2020 opdateret af: Daniel Cox, PhD, University of Virginia
Small amounts of astigmatism are often uncorrected in contact lens wearers. The effect with respect to driving is unknown, but it could threaten safe operation of a motor vehicle, especially under conditions such as nighttime driving when visual abilities are highly challenged. This study measures driving-specific visual abilities and simulated driving performance in participants with astigmatism who either have or do not have their astigmatism corrected. The primary hypothesis is that at a tactical level, contact lenses correcting for astigmatism will result in safer driving performance overall. The secondary hypothesis is that at an operational level, contact lenses correcting for astigmatism will result in better driving-specific visual performance.

Studieoversigt

Detaljeret beskrivelse

Safe driving relies heavily on "good vision." Good vision while driving relates to multiple abilities, such as dynamic visual acuity, contrast sensitivity, management of glare and peripheral vision, etc. While spherical contact lenses address issues of correction of visual acuity as determined by forward static vision tests, if they do not provide visual acuity both immediately and smoothly with eye movement then vision can be compromised. Glare can be a problem as well when contact lenses are off center. Fluctuating vision as a result of lens movement on the eye could be especially problematic and frustrating for patients who have astigmatism. Furthermore, experiencing moments of blurred vision no matter how brief can be potentially hazardous while driving. The 1*DAY ACUVUE® MOIST for ASTIGMATISM contact lenses have a unique blink-activated stabilization system to prevent rotation of the lens on the eye, and may have significant visual advantages for drivers with astigmatism. These lenses provide continuous corrected acuity compared to non-ballasted contact lenses, and thus are potentially safer for driving. Contact comparison will consist of 1*DAY ACUVUE® MOIST (spherical control) versus 1*DAY ACUVUE® MOIST for ASTIGMATISM (the daily disposable astigmatism alternative).

The study will investigate the potential advantages of contact lenses specifically designed to correct for astigmatism, compared to similar correction with spherical contacts, for adult licensed drivers with astigmatism, employing a double-blind (subjects and research assistant blind to hypotheses), randomized, cross-over design (spherical, vs. astigmatism contacts). This will be a multi-stage study comprised of the following:

Preliminary study to determine the likelihood of detecting a significant difference between the standard spherical and astigmatism contacts in a full Randomize Clinical Trial (n=12; data and power analysis)

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

11

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia Driving Safety Lab

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 39 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adult licensed drivers between the ages of 18-39, similar number of males and females will be studied who meet the following inclusion criteria:
  • Bilateral corrected vision of 20/40 or better
  • Bilateral astigmatism between 0.75 to 2.0 diopters, with spherical correction from -1 to -6
  • No active eye infection
  • No defective peripheral vision
  • Do not have correction for bifocals
  • Routinely wear contact lenses more than 4 times per week
  • Routinely drive a car more than 4 times week
  • Do not have a history of motion, sea or big screen (e.g. IMAX) sickness or experience persistent Simulation Adaptation Syndrome

Exclusion Criteria:

  • Bilateral corrected vision of worse than 20/40
  • No astigmatism
  • Active eye infection
  • Defective peripheral vision
  • Wear bifocals
  • Wears contact lenses less than 4 times per week
  • Drives infrequently (less than 4 times per week)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lens sequence 1

No contact lenses; 1-DAY ACUVUE® MOIST contact lenses;

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
Eksperimentel: Lens sequence 2

No contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses;

1-DAY ACUVUE® MOIST contact lenses

spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
Eksperimentel: Lens sequence 3

1-DAY ACUVUE® MOIST contact lenses; No contact lenses;

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses

spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
Eksperimentel: Lens sequence 4

1-DAY ACUVUE® MOIST contact lenses;

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses

spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
Eksperimentel: Lens sequence 5

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses;

1-DAY ACUVUE® MOIST contact lenses; No contact lenses

spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests
Eksperimentel: Lens sequence 6

1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses; No contact lenses;

1-DAY ACUVUE® MOIST contact lenses

spherical contact lenses worn during simulated driving tests
toric contact lenses worn during simulated driving tests
simulated driving tests

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tactical Composite Score
Tidsramme: 1 day laboratory study
Z-score composite of tactical testing outcomes
1 day laboratory study

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Operational Composite Score
Tidsramme: 1 day laboratory study
Z-score composite of operational testing outcomes
1 day laboratory study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Daniel J Cox, Ph.D., University of Virginia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2012

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

30. december 2013

Først indsendt, der opfyldte QC-kriterier

4. december 2015

Først opslået (Skøn)

8. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15920

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med 1-DAY ACUVUE® MOIST contact lenses

Abonner