Health TrialsbyHealthPanel

Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression

ConditionMyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorEssilor International

About this trial

The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:

Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children?

Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression.

Participants will:

* Wear the study spectacles * Visit Essilor R\&D Centre for follow-up sessions

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.

Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.

Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.

Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).

Disqualifiers

Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)

Any binocular vision anomalies

Amblyopia

Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SVL

    Device

    Dispensed to one eye in Year 1

  • SVL with passive red-light emission

    Device

    Dispensed to the contralateral eye in Year 1.

  • MCL

    Device

    Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).

  • MCL with passive red-light emission

    Device

    Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 4 interventions
Group B: Group BExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Change in Axial Length

Time frame
From baseline to 12 months
2

Change in Axial Length

Time frame
From 12 months to 24 months

Secondary outcomes

1

Change in Spherical Equivalent Refraction

Time frame
From baseline to 12 months
2

Change in Spherical Equivalent Refraction

Time frame
From 12 months to 24 months

Other outcomes

Sponsors and contacts

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

Essilor International

Lead sponsor

Source ClinicalTrials.gov
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