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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Myopia Prevention With Reading Glasses

NCT05030103

Myopia

NOT_YET_RECRUITING NA

Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)

NCT01829191

Myopia

COMPLETED NA

Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents

NCT06926556

Myopia Progressing

COMPLETED NA

Long-term Effects of Laser Refractive Surgery

NCT00350246

Myopia

COMPLETED PHASE4

Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses

NCT06221592

Myopia, Progressive

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Myopia control lens

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Myopia control lens

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes