Last updated: September 22, 2022
Sponsor: Paragon Vision Sciences
Overall Status: Active - Recruiting
Phase
N/A
Condition
Myopia
Treatment
N/AClinical Study ID
NCT05389072
SEC-P042021
Ages 6-35 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Are 6- 35 years of age
- Have had a self-reported visual exam in the last two years
- Have a contact lens refraction that fits within the available parameters of the studylenses
- 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.);
- 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;
- Are willing to comply with the wear schedule (8 hour per night for every night, whilesleeping)
- Are willing to comply with the visit schedule
- 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
- Have a refractive spherical component ≥ cylinder component
- Have a minimum visual acuity of +0.20 logMAR with each eye, when refracted at theScreening visit
- Have clear corneas and no active ocular disease
- 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
- Can be shown to have stable keratometry for at least the previous 1 month, if theyhave previously worn orthokeratology lenses.
Exclusion
Exclusion Criteria:
- 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
- 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)
- Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study
- Are pregnant, planning a pregnancy or lactating
- Have amblyopia
- Have presbyopia or has dependence on spectacles for near work over the contact lenses
- Present at screening visit with the presence of clinically significant (grade >3;Efron scale) anterior segment abnormalities.
- Present at screening visit with slit lamp findings that would contraindicateorthokeratology contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm from of the limbus
- Giant papillary conjunctivitis (GPC) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- 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,
SpainSite Not Available
4S Eyecare and Optometry
San Diego, California 92127
United StatesActive - Recruiting
Carillon Vision Care
Glenview, Illinois 60025
United StatesActive - Recruiting
Bellaire Family EyeCare
Bellaire, Texas 77401
United StatesActive - Recruiting
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