NCT05250206

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

Evaluation of Ophthalmic Lenses for Myopia Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Indizen Optical Technologies, S.L.U. · Industry
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Myopia

Interventions

Type	Name	Description
OTHER	Myopia control lens	Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

Timeline

• Start date: 2021-06-07
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2022-02-22
• Last updated: 2025-06-10
• Results posted: 2025-06-10

Locations

1 site across 1 country: Spain