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Evaluating and Improving Functional Driving Vision of Patients With Astigmatism

24. februar 2020 oppdatert av: 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.

Studieoversikt

Detaljert 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)

Studietype

Intervensjonell

Registrering (Faktiske)

11

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • University of Virginia Driving Safety Lab

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

18 år til 39 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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
Eksperimentell: 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
Eksperimentell: 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
Eksperimentell: 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
Eksperimentell: 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
Eksperimentell: 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
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

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

Etterforskere

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

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.

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. september 2012

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først innsendt

30. desember 2013

Først innsendt som oppfylte QC-kriteriene

4. desember 2015

Først lagt ut (Anslag)

8. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 15920

Plan for individuelle deltakerdata (IPD)

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Ubestemt

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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