Effect of a Myopia Control Lens on the Astigmatism in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-13
SponsorEssilor International
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
With the rule astigmatism (defined as vertical meridian has steeper curvature, Astigmatism prescribing axis in between: 0 to 34° and 146 to 180°)
Disqualifiers
An ocular disease
Strabismus
Amblyopia
Trial design
Design model
Single group
Treatments tested in this trial
Lenslet-based myopia control spectacle lens
DeviceDevice 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Myopia Control Lens PrototypeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the Cylinder value through non cycloplegic autorefraction
Time frame
12 monthsSecondary outcomes
1
Change from baseline in the Keratometry value measured using a Keratometer
Time frame
12 months2
Change from baseline in the Axial Length value measured using a biometer
Time frame
12 months3
Quality of Life while wearing the study lenses measured through Questionnaire
PREP 2 questionnaire: Pediatric Refractive Error Profile 2 The questionnaire is designed to assess the vision-specific quality of life in children who wear glasses or contact lenses. It covers seven areas: Vision, Symptoms, Handling, Peer Perception, Activities, Appearance, and Overall. The Child form is a 5 point agreement scale ranging from: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree The parent form is a 10 point agreement scale ranging from 1=likes and 10=dislikes
Time frame
Baseline, 6 and 12 monthsOther outcomes
1
Safety: Change from baseline in the Axial Length value measured using a biometer
Time frame
3 and 6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: