Clinical trial NCT04967287: MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
Official title: MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Digital treatment
Lead sponsor: Dopavision GmbH
Sponsor class: INDUSTRY
First posted: 2021-07-19
Enrollment: 124
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in axial length and in spherical equivalent refractive error
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Change in axial length and in spherical equivalent refractive error
timeFrame: 12 months
measure: Retinal and choroidal imaging parameters
timeFrame: 12 months
measure: Device usability as measured with the user feedback questionnaire
timeFrame: 12 months
Locations:
city: Augsburg
country: Germany
facility: Suedblick GmbH
city: Düsseldorf
country: Germany
facility: MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe
city: Köln
country: Germany
facility: BeyondEye Clinic
city: Mainz
country: Germany
facility: University Medical Center, Johannes Gutenberg- University
city: Tübingen
country: Germany
facility: University Eye Hospital Tübingen
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Braga
country: Portugal
facility: University of Minho
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
city: Madrid
country: Spain
facility: University Complutense of Madrid
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Fundation Trust
Study officials:
affiliation: Centre for Eye Reserach Ireland, Technological University Dublin
name: Ian Flitcroft, Prof.
role: STUDY_CHAIR
References: