MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation (MyopiaX-1)

Dopavision

Status: Completed

Conditions: Myopia

Treatments: Device: Myopia control spectacles; Device: MyopiaX

Study type: Interventional

Funder types: Industry

Identifiers

NCT04967287

MyopiaX-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 124 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

124 participants in 2 patient groups

MyopiaX

Experimental group

Description:

MyopiaX treatment

Treatment:

Device: MyopiaX

Myopia control spectacles

Active Comparator group

Description:

Clinically validated treatment to control myopia

Treatment:

Device: Myopia control spectacles