VOTE: Visual Outcomes for Toric Efficacy Study

Sponsor
University of Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03728218
Collaborator
(none)
34
1
2
17.2
2

Study Details

Study Description

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
  • Device: Contact lenses (Orthokeratology)
  • Device: Contact lenses (Soft Multifocal)
N/A

Study Design

Study Type:
Interventional
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).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 :
Oct 12, 2018
Actual Primary Completion Date :
Mar 19, 2020
Actual Study Completion Date :
Mar 19, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Distance low contrast visual acuity [Up to two hours]

    Monocular and binocular logMAR visual acuity

Secondary Outcome Measures

  1. Residual refractive error measured monocularly by cyclopleged auto-refraction [Up to two hours]

    Cycloplegic auto-refraction to measure residual myopia/hyperopia and astigmatism

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Houston Houston Texas United States 77204

Sponsors and Collaborators

  • University of Houston

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kathryn Richdale, Associate Professor, University of Houston
ClinicalTrials.gov Identifier:
NCT03728218
Other Study ID Numbers:
  • STUDY00001070
First Posted:
Nov 2, 2018
Last Update Posted:
Jul 14, 2020
Last Verified:
Jul 1, 2020
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:

Study Results

No Results Posted as of Jul 14, 2020