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- Klinische proef NCT02624791
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22908
- University of Virginia Driving Safety Lab
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Tactical Composite Score
Tijdsspanne: 1 day laboratory study
|
Z-score composite of tactical testing outcomes
|
1 day laboratory study
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Operational Composite Score
Tijdsspanne: 1 day laboratory study
|
Z-score composite of operational testing outcomes
|
1 day laboratory study
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Daniel J Cox, Ph.D., University of Virginia
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 15920
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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