NCT04967287

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
5 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2024

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

2.9 years

First QC Date

July 7, 2021

Last Update Submit

October 24, 2024

Conditions

Myopia

Keywords

Digital treatment

Outcome Measures

Primary Outcomes (1)

  • Change in axial length and in spherical equivalent refractive error

    Change in axial length (mm) and in spherical equivalent refractive error )D)from baseline to month 6.

    6 months

Other Outcomes (3)

  • Change in axial length and in spherical equivalent refractive error

    12 months

  • Retinal and choroidal imaging parameters

    12 months

  • Device usability as measured with the user feedback questionnaire

    12 months

Study Arms (2)

MyopiaX

EXPERIMENTAL

MyopiaX treatment

Device: MyopiaX

Myopia control spectacles

ACTIVE COMPARATOR

Clinically validated treatment to control myopia

Device: Myopia control spectacles

Interventions

MyopiaXDEVICE

MyopiaX treatment twice a day

MyopiaX
Myopia control spectaclesDEVICE

To be used all as prescribed

Myopia control spectacles

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Suedblick GmbH

Augsburg, Germany

Location

BeyondEye Clinic

Cologne, Germany

Location

MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe

Düsseldorf, 40549, Germany

Location

University Medical Center, Johannes Gutenberg- University

Mainz, Germany

Location

University Eye Hospital Tübingen

Tübingen, Germany

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

University of Minho

Braga, Portugal

Location

Hospital Sant Joan de Déu

Barcelona, Spain

Location

University Complutense of Madrid

Madrid, Spain

Location

Moorfields Eye Hospital NHS Fundation Trust

London, United Kingdom

Location

Related Publications (1)

  • Loughman J, Lingham G, Kaymak H, Lorenz K, Polling JR, Beck A, Carracedo G, Dahlmann-Noor AH, Muller PL, Flitcroft I; MyopiaX-1 Study Group. MyopiaX-1 Safety and Efficacy of a Novel Approach to Slow Juvenile Myopia Progression: A Multicenter, Randomized, Controlled Trial. Ophthalmol Sci. 2025 Oct 10;6(1):100973. doi: 10.1016/j.xops.2025.100973. eCollection 2026 Jan.

    PMID: 41438818DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Ian Flitcroft, Prof.

    Centre for Eye Reserach Ireland, Technological University Dublin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 19, 2021

Study Start

November 16, 2021

Primary Completion

October 4, 2024

Study Completion

October 4, 2024

Last Updated

October 28, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)GB(1)DE(5)PT(1)NL(1)