Visual Outcomes for Toric Efficacy Study

Myopia Clinical Trial

— VOTE  

Official title:

Visual Outcomes for Toric Efficacy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728218
• Other study ID #: STUDY00001070
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: March 19, 2020

Study information

• Verified date: July 2020
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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)

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

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

Locations

Country	Name	City	State
United States	University of Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

References & Publications (11)

Benavente-Pérez 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutiérrez-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. — View 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. — View 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance low contrast visual acuity	Monocular and binocular logMAR visual acuity	Up to two hours
Secondary	Residual refractive error measured monocularly by cyclopleged auto-refraction	Cycloplegic auto-refraction to measure residual myopia/hyperopia and astigmatism	Up to two hours

External Links

•   Lab website