Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes

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 will be 3 years including a total of 5 visits.

The sample will consist of a group of 92 myopic children who will be randomly assigned to one of the treatment groups:

• Control group who will receive standard monofocal lenses.
• Treatment group who will wear a prototype lens based on peripheral positive defocus.

Inclusion criteria

• 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 criteria

• 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.