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OpenTrials
Completed

NCT Number: NCT03728218

Visual Outcomes for Toric Efficacy Study

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.

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Key information

Conditions

Astigmatism Eye Diseases Myopia Refractive Errors

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Houston

Houston, Texas, 77204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Contact lenses (Orthokeratology)

Device

Contact lenses

Contact lenses (Soft Multifocal)

Device

Contact lenses

Primary outcomes

  1. Distance low contrast visual acuity

    Time frame: Up to two hours

    Monocular and binocular logMAR visual acuity

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Registry information

Acronym: VOTE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 2, 2018
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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