Status:
ACTIVE_NOT_RECRUITING
Myopia Adjustment Using Dual-intervention: Red-Light Therapy & Innovative Design in Orthokeratology
Lead Sponsor:
Centro de Miopía Fernández-Velázquez
Conditions:
MYOPIA
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
This clinical trial investigates the efficacy of combining orthokeratology (OK) lenses with repeated low-level red-light (R.L.R.L.) therapy in slowing the progression of myopia in children classified ...
Detailed Description
Background and Rationale Myopia is a growing public health concern worldwide, especially among children, due to its progressive nature and association with severe ocular complications later in life. O...
Eligibility Criteria
Inclusion
- Children aged 8 to 15 years. Intention to undergo orthokeratology (OK) lens treatment. Spherical equivalent refractive error between -1.00 and -4.00 diopters in either eye.
- Astigmatism no greater than 1.50 D in either eye. Best corrected visual acuity (BCVA) of 25/25 or better in both eyes. Birth weight of at least 1500 g. Classified as ortho-k non-responders: continued OK use with persistent rapid myopia progression.
- Willingness of child and legal guardian to participate and attend follow-up visits.
- Signed informed consent by parent or guardian.
Exclusion
- cular conditions such as strabismus, amblyopia, cataract, or ptosis. Previous use of OK lenses or atropine for myopia control. Contraindications to atropine (e.g., known allergy, cardiovascular disease, epilepsy).
- Ocular contraindications to OK lens wear (e.g., inflammation, infection). Systemic diseases that may affect ocular growth (e.g., Down syndrome, Marfan syndrome).
- Any other ocular disease that could interfere with study outcomes.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06899139
Start Date
March 1 2024
End Date
December 31 2025
Last Update
March 27 2025
Active Locations (1)
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1
Centro de Miopia Fernandez-Velazquez
Madrid, Madrid, Spain, 28029