MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2024-10-04

Brief Summary

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

The purpose of this trial is to investigate the safety and efficacy of MyopiaX - a digital treatment intended to slow the progression of myopia in children and adolescents.

Related Clinical Trials

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

Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model

NCT05357326

Myopia

UNKNOWN PHASE4

A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children

NCT06305663

Myopia

RECRUITING NA

Light Diffraction Glasses in Preventing and Controlling Myopia in Adolescents

NCT06927414

Myopia Progressing

ACTIVE_NOT_RECRUITING NA

3D Designed Defocus Lenses on Myopia Control in Children and Adolescents

NCT07284147

Myopia Progressing

ENROLLING_BY_INVITATION NA

Efficacy and Tolerance of Full Field Peripheral Defocus Spectacles for the Control of Myopia Progression (Myofix Study)

NCT07092072

Myopia Progression

COMPLETED NA

Detailed Description

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

The present study is a multicentric, randomized, controlled, single masked trial to investigate the signals of effect, the safety and tolerability of MyopiaX in slowing the progression of myopia.

The trial consists of 12 months treatment period. The first 6 months participants will be treated either with MyopiaX or with myopia control spectacles. During the second half of the trial, participants treated with MyopiaX will receive the myopia control spectacles in addition. 81 children and adolescent aged 6 - 12 years will be included in the trial. Eligible subjects will be randomly assigned in a 2:1 ratio to either the MyopiaX or the myopia control spectacles group.

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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

MyopiaX

MyopiaX treatment

Group Type EXPERIMENTAL

MyopiaX

Intervention Type DEVICE

MyopiaX treatment twice a day

Myopia control spectacles

Clinically validated treatment to control myopia

Group Type ACTIVE_COMPARATOR

Myopia control spectacles

Intervention Type DEVICE

To be used all as prescribed

Interventions

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

MyopiaX

MyopiaX treatment twice a day

Intervention Type DEVICE

Myopia control spectacles

To be used all as prescribed

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Myopic children (-0.75 to -5.0 D SER, least myopic meridian -0.50 D in each eye)
* At least VA 0.2 LogMAR in each eye
* Age: 6 - 12 years old
* Good tolerability of test session with VR system
* Binocular adequacy as tested with VR
* Ability to understand treatment and give valid assent

Exclusion Criteria

* Concomitant or previous therapies for myopia
* Eye diseases/conditions:
* Anisometropia ≥ 1.5 D
* Astigmatism ≥ 3 D
* Ophthalmological comorbidities
* Optic nerve abnormalities
* Suspicion of syndromic or monogenetic myopia
* Systemic illnesses affecting eye health, eye growth, and/or refraction
* Any illnesses affecting dopamine function (e.g., sleep disorder)
* Medication affecting dopamine function, accommodation, pupil size, or having an impact on the ocular surface (such as allergy medications)
* Participation in other clinical studies
* Medical history (or family history) of photosensitive epilepsy

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No