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

Indizen Optical Technologies, S.L.U.92 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Myopia

Interventions

Myopia control lensOTHER

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Universidad Europea of Madrid

Madrid, Spain

Outcomes

Primary Outcomes

Axial Lenght Increase

Axial length was measured with the IOL Master® optical biometer (Carl Zeiss Meditec, Jena, Germany) and axial length growth was calculated by subtracting the axial length measurement after one year of treatment and the axial length at the initial visit.

Time frame: 5 minutes

Data from ClinicalTrials.gov

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