Clinical trial NCT03728218: Visual Outcomes for Toric Efficacy Study
Official title: Visual Outcomes for Toric Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Myopia
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals).
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Distance low contrast visual acuity
timeFrame: Up to two hours
Secondary outcomes:
measure: Residual refractive error measured monocularly by cyclopleged auto-refraction
timeFrame: Up to two hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.