Health TrialsbyHealthPanel

Early Intervention for High Risk Premyopic Children

ConditionMyopia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-6
SponsorNational Yang Ming Chiao Tung University Hospital

About this trial

The purpose of this research project is to add evidence of pharmacological (0.025% atropine) and optical (Defocus Integrated Multiple Segments Triple Enhanced Design spectacle lenses ) approaches for myopia prevention among premyopic preschoolers, which may contribute to a better understanding of the intervention strategy for myopia control in premyopic children.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age at enrollment: 5-6 years old (the senior grade of kindergarten)

Cycloplegic SE of the eye with less SE (less positive or more negative refractive error): < +1.00 D and > -0.50 D

Astigmatism: 1.5 D or less in both eyes

Anisometropia: 1.50 D or less

Disqualifiers

Strabismus or any ocular motility disorder

Any ophthalmic and systemic disorders that might affect visual functions or refractive development

Previous treatment of atropine or other myopia control intervention

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.025% atropine eye drops

    Drug

    Daily instillation of 0.025% atropine

  • DIMS TED

    Device

    Stepwise wearing of DIMS TED

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: DIMS TEDActive comparator 1 intervention
Group B: 0.025% AtropineActive comparator 1 intervention
Group C: Normal activitiesNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Myopic shift of spherical equivalent refraction

The change of mean cycloplegic spherical equivalent refraction over 7 years

Time frame
7 years

Secondary outcomes

1

Axial length elongation

The change of mean axial length over 7 years

Time frame
7 years
2

Incidence of myopia

the cumulative percentage of incident myopia

Time frame
7 years
3

Fast myopic shift of spherical equivalent refraction

the cumulative percentage of fast myopic shift of spherical equivalent refraction

Time frame
7 years
4

Subfoveal choroidal thickness

the vertical distance from the outer edge of the retinal pigment epithelium (or Bruch's membrane) to the inner surface of the sclera (the chorioscleral border) directly beneath the fovea

Time frame
7 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Yang Ming Chiao Tung University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: