Effect of a Myopia Control Lens on the Astigmatism in Children (MAC)
A Monocentre, Single-Arm Trial to Study the Effect of Lens Inspired by Myopia Control Solutions on the Astigmatism of a Child
The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism.
The main question it aims to answer is:
- How does the eye respond at each timepoint to the myopia control lenses?
By evaluating: the change in astigmatism (cylinder) after one year?
Participants will:
Wear the assigned study spectacles daily
Visit the Essilor R&D Centre for scheduled follow-up sessions
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas Boudenne
- Email: thomas.boudenne@essilor.com
Study Contact Backup
- Name: Celine Carimalo
- Phone Number: +65 67134600
- Email: carimalc@essilor.com.sg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteer participant
- Informed consent of parent or guardian and assent of participant
- Age equal to or greater than 6 years and less than 13 years (before 13th birthday) at the time of consent.
Refractive error (manifest refraction):
- With the rule astigmatism (defined as vertical meridian has steeper curvature, Astigmatism prescribing axis in between: 0 to 34° and 146 to 180°)
- Astigmatism should be more than or equal to 1.50D
- Least myopic meridian equal or less than -0.50D
- Most myopic meridian equal or greater than -5.50D.
- Anisometropia should be less than or equal to 1.00D
- Best corrected visual acuity: Better than 0.2 logMAR in each eye
Willingness and ability to:
- participate in trial for at least 12 months.
- attend scheduled visits.
- not to be involved in other myopia control treatments concurrently.
- No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
Exclusion Criteria:
History or presence of:
- An ocular disease
- Strabismus
- Amblyopia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Myopia Control Lens Prototype
Each participant will be fitted with a prototype lenslet-based spectacle lens to be worn continuously throughout the 12-month study period. Following the baseline and dispensing visit, participants will undergo follow-up assessments at 3, 6, and 12 months. These intervals will monitor change of myopia and astigmatism through standard refraction and ocular biometry measurements. Device Details: The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). The lenses will be dispensed and worn daily for the duration of the 12-month evaluation period. |
Device Details: The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). In this specific device, the lenslet are located in concentric rings. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in the Cylinder value through non cycloplegic autorefraction
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in the Keratometry value measured using a Keratometer
Time Frame: 12 months
|
12 months
|
|
Change from baseline in the Axial Length value measured using a biometer
Time Frame: 12 months
|
12 months
|
|
Quality of Life while wearing the study lenses measured through Questionnaire
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety: Change from baseline in the Axial Length value measured using a biometer
Time Frame: 3 and 6 months
|
3 and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Si Ying Lim, EssilorLuxottica
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WS10487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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