- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02624791
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
Studieoversikt
Status
Forhold
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Virginia
-
Charlottesville, Virginia, Forente stater, 22908
- University of Virginia Driving Safety Lab
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
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
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Daniel J Cox, Ph.D., University of Virginia
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15920
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