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Visual Outcomes for Toric Efficacy Study (VOTE)

Primary Purpose

Astigmatism, Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contact lenses (Orthokeratology)
Contact lenses (Soft Multifocal)
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Astigmatism

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Orthokeratology Contact lenses

Soft Multifocal Contact lenses

Arm Description

Outcomes

Primary Outcome Measures

Distance low contrast visual acuity
Monocular and binocular logMAR visual acuity

Secondary Outcome Measures

Residual refractive error measured monocularly by cyclopleged auto-refraction
Cycloplegic auto-refraction to measure residual myopia/hyperopia and astigmatism

Full Information

First Posted
October 29, 2018
Last Updated
July 10, 2020
Sponsor
University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03728218
Brief Title
Visual Outcomes for Toric Efficacy Study
Acronym
VOTE
Official Title
Visual Outcomes for Toric Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
March 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism, Myopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orthokeratology Contact lenses
Arm Type
Experimental
Arm Title
Soft Multifocal Contact lenses
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Contact lenses (Orthokeratology)
Intervention Description
Contact lenses
Intervention Type
Device
Intervention Name(s)
Contact lenses (Soft Multifocal)
Intervention Description
Contact lenses
Primary Outcome Measure Information:
Title
Distance low contrast visual acuity
Description
Monocular and binocular logMAR visual acuity
Time Frame
Up to two hours
Secondary Outcome Measure Information:
Title
Residual refractive error measured monocularly by cyclopleged auto-refraction
Description
Cycloplegic auto-refraction to measure residual myopia/hyperopia and astigmatism
Time Frame
Up to two hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14972717
Citation
Cheung SW, Cho P. Subjective and objective assessments of the effect of orthokeratology--a cross-sectional study. Curr Eye Res. 2004 Feb;28(2):121-7. doi: 10.1076/ceyr.28.2.121.26236.
Results Reference
background
PubMed Identifier
23838771
Citation
Berntsen DA, Barr CD, Mutti DO, Zadnik K. Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses. Invest Ophthalmol Vis Sci. 2013 Aug 27;54(8):5761-70. doi: 10.1167/iovs.13-11904.
Results Reference
background
PubMed Identifier
26283026
Citation
Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R, Suzaki A. The effects of entrance pupil centration and coma aberrations on myopic progression following orthokeratology. Clin Exp Optom. 2015 Nov;98(6):534-40. doi: 10.1111/cxo.12297. Epub 2015 Aug 17.
Results Reference
background
PubMed Identifier
25190657
Citation
Benavente-Perez A, Nour A, Troilo D. Axial eye growth and refractive error development can be modified by exposing the peripheral retina to relative myopic or hyperopic defocus. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6765-73. doi: 10.1167/iovs.14-14524.
Results Reference
background
PubMed Identifier
12912692
Citation
Kleinstein RN, Jones LA, Hullett S, Kwon S, Lee RJ, Friedman NE, Manny RE, Mutti DO, Yu JA, Zadnik K; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study Group. Refractive error and ethnicity in children. Arch Ophthalmol. 2003 Aug;121(8):1141-7. doi: 10.1001/archopht.121.8.1141.
Results Reference
background
PubMed Identifier
24076542
Citation
Berntsen DA, Kramer CE. Peripheral defocus with spherical and multifocal soft contact lenses. Optom Vis Sci. 2013 Nov;90(11):1215-24. doi: 10.1097/OPX.0000000000000066.
Results Reference
background
PubMed Identifier
18804868
Citation
Van Meter WS, Musch DC, Jacobs DS, Kaufman SC, Reinhart WJ, Udell IJ; American Academy of Ophthalmology. Safety of overnight orthokeratology for myopia: a report by the American Academy of Ophthalmology. Ophthalmology. 2008 Dec;115(12):2301-2313.e1. doi: 10.1016/j.ophtha.2008.06.034. Epub 2008 Sep 20.
Results Reference
background
PubMed Identifier
26016072
Citation
Luo M, Ma S, Liang N. Clinical efficacy of toric orthokeratology in myopic adolescent with moderate to high astigmatism. Eye Sci. 2014 Dec;29(4):209-13, 218.
Results Reference
background
PubMed Identifier
24003088
Citation
Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527.
Results Reference
background
PubMed Identifier
30214344
Citation
Zimmerman AB, Nixon AD, Rueff EM. Contact lens associated microbial keratitis: practical considerations for the optometrist. Clin Optom (Auckl). 2016 Jan 29;8:1-12. doi: 10.2147/OPTO.S66424. eCollection 2016.
Results Reference
background
PubMed Identifier
23892491
Citation
Bullimore MA, Sinnott LT, Jones-Jordan LA. The risk of microbial keratitis with overnight corneal reshaping lenses. Optom Vis Sci. 2013 Sep;90(9):937-44. doi: 10.1097/OPX.0b013e31829cac92.
Results Reference
background
PubMed Identifier
32568927
Citation
Tomiyama ES, Logan AK, Richdale K. Corneal Elevation, Power, and Astigmatism to Assess Toric Orthokeratology Lenses in Moderate-to-High Astigmats. Eye Contact Lens. 2021 Feb 1;47(2):86-90. doi: 10.1097/ICL.0000000000000721.
Results Reference
derived

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Visual Outcomes for Toric Efficacy Study

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