Health TrialsbyHealthPanel

Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children

ConditionsMyopiaMyopia Progression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorSingapore National Eye Centre

About this trial

This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All ethnicities

Age between 6 and 15 years

Refraction -0.50D till - 7.00D and astigmatism ≤ 3.00D

Anisometropia ≤ 3.00D

Disqualifiers

Ocular and systemic abnormalities

Children who do not cooperate

Binocular vision anomalies (strabismus, suppression)

Previous use of myopia management treatment (spectacles, atropine, CLs)

Trial design

Design model

Parallel

Treatments tested in this trial

  • EYE001

    Device

    Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic

Treatment groups

202 Participants
are divided into 2 treatment groups
Group A: Children on clear DIMS lensesActive comparator 1 intervention
Group B: Children on photochromic DIMS lensesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comparing photochromic DIMS spectacles lenses performance (PDIMS) versus clear DIMS spectacles lenses (DIMS)

The primary objective of this study is to evaluate the efficacy of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in terms of childhood myopia control (cycloplegic spherical equivalent refraction (SER), axial elongation and choroidal thickness).

Time frame
24 months

Secondary outcomes

1

Performance of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS)

To assess the safety, tolerability (quality of life (QoL)), and adaptation to PDIMS lens wear compared to DIMS lens wear.

Time frame
24 months

Other outcomes

Sponsors and contacts

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

Singapore National Eye Centre

Lead sponsor

Source ClinicalTrials.gov

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