N/A N=92 Prevention

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

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT05250206 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Axial Lenght Increase — 0.27; 0.37 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Myopia control lens (Other)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Indizen Optical Technologies, S.L.U.
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Axial Lenght Increase	0.27; 0.37	—

Summary

Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05250206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.