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.

92 children were enrolled and 23 of the participants did not complete the study. Thus, the final sample was 69 children.

From baseline through 24 months of follow-up

Adverse events were monitored continuously from baseline to study completion (24 months). Only participants who completed the study were included in the final safety analysis (n=69).