Visual Outcomes for Toric Efficacy Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03728218

Acronym

VOTE

Enrollment

Registered

2018-11-02

Start date

2018-10-12

Completion date

2020-03-19

Last updated

2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Myopia

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.

Interventions

DEVICEContact lenses (Orthokeratology)

Contact lenses

DEVICEContact lenses (Soft Multifocal)

Contact lenses

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals).

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Distance low contrast visual acuity	Up to two hours	Monocular and binocular logMAR visual acuity

Secondary

Measure	Time frame	Description
Residual refractive error measured monocularly by cyclopleged auto-refraction	Up to two hours	Cycloplegic auto-refraction to measure residual myopia/hyperopia and astigmatism

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026