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

May 22, 2025 updated by: Indizen Optical Technologies, S.L.U.

Evaluation of Ophthalmic Lenses for Myopia Management

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28670
        • Universidad Europea of Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Axial lenght increase
Children aged 5 to 12 with myopia up to -0.50 D, astigmatism and anisometropia under 1.50 D, and corrected visual acuity over 20/20 will be randomized to either the control group or treatment group. The myopia progression was evaluated by measuring axial length (AL) growth (IOL Master; Zeiss) over a period of one year.
Other: Myopia control lens
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial Lenght Increase
Time Frame: 5 minutes
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.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indizen Optical Technologies, S.L.U.

Collaborators

Universidad Europea de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOT-MIO-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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