Evaluation of The Comfort of Orthokeratology Lenses Fit Using A New Software

Last updated: September 22, 2022
Sponsor: Paragon Vision Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

N/A

Clinical Study ID

NCT05389072
SEC-P042021
  • Ages 6-35
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

As new orthokeratology fitting software emerges onto the market, it is of interest to assess their usefulness in guiding eye practitioners with lens fit. The goal of this study is to evaluate the comfort of Paragon orthokeratology lenses when they are fit using the new Procornea software.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Are 6- 35 years of age
  2. Have had a self-reported visual exam in the last two years
  3. Have a contact lens refraction that fits within the available parameters of the studylenses
  4. Are able to read (or be read to), understand and sign the assent document if under 18years old or are able to read, understand and sign the consent document if aged 18 orolder (Children 6-years of age will not be asked to sign the assent form as perSTERLING IRB.);
  5. Are under 18 years old and are accompanied by a parent or legal guardian who is ableto read, understand and sign the parental information and permission document;
  6. Are willing to comply with the wear schedule (8 hour per night for every night, whilesleeping)
  7. Are willing to comply with the visit schedule
  8. Have a refractive spherical component of their prescription between -0.50 and up to -6.00 diopters (inclusive) AND a refractive cylinder of no more than -1.75 diopters
  9. Have a refractive spherical component ≥ cylinder component
  10. Have a minimum visual acuity of +0.20 logMAR with each eye, when refracted at theScreening visit
  11. Have clear corneas and no active ocular disease
  12. Have no medication, medical condition, or ocular conditions that contraindicatecontact wear OR are expected to affect lens comfort or vision across the 1-month studyduration, in the opinion of the investigator
  13. Can be shown to have stable keratometry for at least the previous 1 month, if theyhave previously worn orthokeratology lenses.

Exclusion

Exclusion Criteria:

  1. Present at screening visit with the presence of ocular or systemic disease or reportsthe use medications which might interfere with orthokeratology contact lens wear, suchas keratoconus, diabetes mellitus, steroid eye drops
  2. Have a post-treatment predicted flat K value ≤38.00D (e.g. Patient baseline flatkeratometry value = 40.00, patient has 2.00D of myopic refractive error. 40.00-2.00= 38.00D)
  3. Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study
  4. Are pregnant, planning a pregnancy or lactating
  5. Have amblyopia
  6. Have presbyopia or has dependence on spectacles for near work over the contact lenses
  7. Present at screening visit with the presence of clinically significant (grade >3;Efron scale) anterior segment abnormalities.
  8. Present at screening visit with slit lamp findings that would contraindicateorthokeratology contact lens wear such as:
  9. Pathological dry eye or associated findings
  10. Pterygium, pinguecula, or corneal scars within the visual axis
  11. Neovascularization > 0.75 mm from of the limbus
  12. Giant papillary conjunctivitis (GPC) worse than grade 1
  13. Anterior uveitis or iritis (past or present)
  14. Seborrheic eczema, Seborrheic conjunctivitis
  15. History of corneal ulcers or fungal infections
  16. Poor personal hygiene
  17. Aphakia

Study Design

Total Participants: 57
Study Start date:
June 01, 2022
Estimated Completion Date:
May 31, 2023

Connect with a study center

  • University Complutense of Madrid

    Madrid,
    Spain

    Site Not Available

  • 4S Eyecare and Optometry

    San Diego, California 92127
    United States

    Active - Recruiting

  • Carillon Vision Care

    Glenview, Illinois 60025
    United States

    Active - Recruiting

  • Bellaire Family EyeCare

    Bellaire, Texas 77401
    United States

    Active - Recruiting

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