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Visual Outcomes for Toric Efficacy Study (VOTE)

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University of Houston

Status

Completed

Conditions

Myopia
Astigmatism

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03728218
STUDY00001070

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Orthokeratology Contact lenses
Experimental group
Treatment:
Device: Contact lenses (Orthokeratology)
Soft Multifocal Contact lenses
Experimental group
Treatment:
Device: Contact lenses (Soft Multifocal)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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