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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

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.

Condition or disease Intervention/treatment Phase
Astigmatism Myopia Device: Contact lenses (Orthokeratology) Device: Contact lenses (Soft Multifocal) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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
Official Title: Visual Outcomes for Toric Efficacy Study
Actual Study Start Date : October 12, 2018
Actual Primary Completion Date : March 19, 2020
Actual Study Completion Date : March 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Orthokeratology Contact lenses Device: Contact lenses (Orthokeratology)
Contact lenses

Experimental: Soft Multifocal Contact lenses Device: Contact lenses (Soft Multifocal)
Contact lenses




Primary Outcome Measures :
  1. Distance low contrast visual acuity [ Time Frame: Up to two hours ]
    Monocular and binocular logMAR visual acuity


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728218


Locations
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United States, Texas
University of Houston
Houston, Texas, United States, 77204
Sponsors and Collaborators
University of Houston
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kathryn Richdale, Associate Professor, University of Houston
ClinicalTrials.gov Identifier: NCT03728218    
Other Study ID Numbers: STUDY00001070
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

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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
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases