Status:
COMPLETED
Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes
Lead Sponsor:
Indizen Optical Technologies, S.L.U.
Collaborating Sponsors:
Universidad Europea de Madrid
Conditions:
Myopia
Eligibility:
All Genders
5-12 years
Phase:
NA
Brief Summary
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.
Detailed Description
A prospective, double-blind, randomized clinical trial (RCT) to analyze the effect of a new ophthalmic lens prototype on myopia progression. The follow-up period to evaluate the efficacy of the lens w...
Eligibility Criteria
Inclusion
- Age: 5 to 12 years old
- Myopia (spherical equivalent with cycloplegic) ≤ -0.50D
- Astigmatism \< 1.50D
- Anisometropia \< 1.50D
- Best-corrected visual acuity ≥ 20/20
Exclusion
- Patients who have received any previous treatment for myopia control, including the use of RPG contact lenses.
- Participants with ocular pathology such as retinal detachment.
- Participants using drugs that may affect pupillary size and accommodation or that produce effects on the ocular surface.
- Participants with systemic diseases that may affect vision.
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05250206
Start Date
June 7 2021
End Date
November 30 2024
Last Update
June 10 2025
Active Locations (1)
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1
Universidad Europea of Madrid
Madrid, Spain, 28670