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Visual Outcomes for Toric Efficacy Study (VOTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728218
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Kathryn Richdale, University of Houston

Tracking Information
First Submitted Date  ICMJE October 29, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date July 14, 2020
Actual Study Start Date  ICMJE October 12, 2018
Actual Primary Completion Date March 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Distance low contrast visual acuity [ Time Frame: Up to two hours ]
Monocular and binocular logMAR visual acuity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Residual refractive error measured monocularly by cyclopleged auto-refraction [ Time Frame: Up to two hours ]
Cycloplegic auto-refraction to measure residual myopia/hyperopia and astigmatism
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Visual Outcomes for Toric Efficacy Study
Official Title  ICMJE Visual Outcomes for Toric Efficacy Study
Brief Summary This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals). Primary aims are to quantify correction of astigmatism, subjective and objective visual performance, aberrometry, peripheral refraction and bacterial bioburden between toric orthokeratology and soft toric multifocal contact lenses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals).
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Astigmatism
  • Myopia
Intervention  ICMJE
  • Device: Contact lenses (Orthokeratology)
    Contact lenses
  • Device: Contact lenses (Soft Multifocal)
    Contact lenses
Study Arms  ICMJE
  • Experimental: Orthokeratology Contact lenses
    Intervention: Device: Contact lenses (Orthokeratology)
  • Experimental: Soft Multifocal Contact lenses
    Intervention: Device: Contact lenses (Soft Multifocal)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2020)
34
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
40
Actual Study Completion Date  ICMJE March 19, 2020
Actual Primary Completion Date March 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 39 years of age (inclusive)
  • Able to read and understand the study informed consent
  • Plano to -5.00 D (inclusive) vertex corrected sphere power in each eye
  • 1.25 to -3.50 D (inclusive) vertex corrected astigmatism in each eye
  • Best corrected acuity of 20/25 or better in each eye
  • No history of ocular pathology or surgery
  • No significant binocular vision or accommodation abnormality (i.e. strabismus, amblyopia)
  • No gas permeable lens wear for at least 1 month
  • No systemic or ocular contraindications for contact lens wear
  • Not pregnant/lactating (by self-report)

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners
  • Students for whom one of the principal investigators have direct access to/influence on grades would be consented and seen by another investigator for all visits.
  • Pregnant/lactating women (by self-report)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728218
Other Study ID Numbers  ICMJE STUDY00001070
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kathryn Richdale, University of Houston
Study Sponsor  ICMJE University of Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Houston
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP