Myopia Control With Orthokeratology Contact Lenses in Spain (NCT04806763) | Clinical Trial Compass
CompletedNot Applicable
Myopia Control With Orthokeratology Contact Lenses in Spain
69 participantsStarted 2007-03-01
Plain-language summary
The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children.
Who can participate
Age range6 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be 6 to 12 years of age, both ages inclusive
* A low-to-moderate level of myopia (between -0.75 and -4.00 D) and of astigmatism (≤ 1.00 D)
* Neophyte contact lens wearer
* Be successfully fitted with spectacles or orthokeratology contact lenses
* Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye
* Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits
* White European ethnicity
Exclusion Criteria:
* Systemic or ocular disease affecting ocular health
* Use of any systemic or topical medications that could affect ocular physiology or contact lens performance
* Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated
* CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs
* Aphakic, amblyopic, and atopic individuals
* Refractive astigmatism ≥ ½ spherical refraction
* Previous contact lens wear