Visual Outcomes for Toric Efficacy Study

NCT03728218 | Completed FDA Device

• 1 other identifier: STUDY00001070
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism; Myopia

Outcome Measures

Primary Outcomes (1)

• Distance low contrast visual acuity

  Monocular and binocular logMAR visual acuity

  Up to two hours

Secondary Outcomes (1)

• Residual refractive error measured monocularly by cyclopleged auto-refraction

  Up to two hours

Study Arms (2)

Orthokeratology Contact lenses

EXPERIMENTAL

Device: Contact lenses (Orthokeratology)

Soft Multifocal Contact lenses

EXPERIMENTAL

Device: Contact lenses (Soft Multifocal)

Interventions

Contact lenses (Orthokeratology) DEVICE

Contact lenses

Orthokeratology Contact lenses

Contact lenses (Soft Multifocal) DEVICE

Contact lenses

Soft Multifocal Contact lenses

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

Related Publications (13)

• 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.

  PMID: 14972717 BACKGROUND

• 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.

  PMID: 23838771 BACKGROUND

• 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.

  PMID: 26283026 BACKGROUND

• 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.

  PMID: 25190657 BACKGROUND

• 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.

  PMID: 12912692 BACKGROUND

• 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.

  PMID: 24076542 BACKGROUND

• 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.

  PMID: 18804868 BACKGROUND

• 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.

  PMID: 26016072 BACKGROUND

• 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.

  PMID: 24003088 BACKGROUND

• 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.

  PMID: 30214344 BACKGROUND

• 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.

  PMID: 23892491 BACKGROUND

• Tomiyama ES, Richdale K. Clinical Outcomes of a Randomized Trial with Contact Lenses for Astigmatic Myopia Management. Optom Vis Sci. 2023 Jan 1;100(1):9-16. doi: 10.1097/OPX.0000000000001969. Epub 2022 Dec 6.

  PMID: 36705710 DERIVED

• 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.

  PMID: 32568927 DERIVED

MeSH Terms

Conditions

Astigmatism; Myopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 2, 2018
• Study Start: October 12, 2018
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

US (1)