Health TrialsbyHealthPanel

Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia

ConditionsMyopiaMyopia Progression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorEssilor International

About this trial

The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.

The main question being studied is:

Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?

In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.

Participants will:

* Wear the study spectacles for 12 months. * Attend scheduled follow-up visits at the Essilor R\&D Centre, Singapore.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteer participant with the willingness and ability to comply with all scheduled study visits.

Informed consent of parent/guardian and assent of participant.

Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.

Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.

Disqualifiers

History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.

Strabismus by cover test at near or distance wearing correction.

History and presence of amblyopia.

Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).

Trial design

Design model

Crossover

Treatments tested in this trial

  • Investigational Myopia Control Spectacle Lens

    Device

    A spectacle lens designed to help slow the progression of myopia in children

  • Single Vision Spectacle Lens

    Device

    A standard spectacle lens used to correct refractive error without a specific myopia control feature

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: OD: SVL; OS: MCL then OD: MCL; OS: SVLExperimental treatment 2 interventions
Group B: OD: MCL; OS: SVL then OD: SVL; OS: MCLExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Eye Axial Length

Time frame
From baseline to 6 months

Secondary outcomes

1

Change in Eye Axial Length

Time frame
From 6 months to 12 months
2

Change in Eye Non-Cycloplegic Spherical Equivalent Refraction

Time frame
From baseline to 6 months
3

Change in Eye Non-Cycloplegic Spherical Equivalent Refraction

Time frame
From 6 months to 12 months

Other outcomes

Sponsors and contacts

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

Essilor International

Lead sponsor

Source ClinicalTrials.gov

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