Targeted Lens Intervention for Myopic Anisometropia in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-13
SponsorEssilor International
About this trial
The goal of this clinical trial is to learn if our research spectacles will lower the difference in prescription (spectacles degree) between the eyes in children between 6 to 13 years old with anisometropic myopia. Anisometropic myopia is when the difference in myopia prescription between the two eyes are more than 1 diopter. The main question it aims to answer is:
* How the eye responds to the research spectacles over time by measuring:
1. Change in axial length: the physical length of the eye from front to back. 2. Change in cycloplegic spherical equivalent refraction: an accurate measurement of the eye's prescription taken while the focusing muscles are temporarily relaxed with eye drops.
Participants will: * Wear the study spectacles * Visit Essilor R\&D Centre and an eye clinic for follow-up sessions
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary
Informed consent of parent/guardian and assent of participant
Age equal to or greater than 6 years old and less than 13 years at the time of signing informed consent and assent
SER equal or less than -0.50 D and equal or greater than .5.00 D with astigmatism not more than 2.50 D
Disqualifiers
History or presence of an ocular disease affecting refractive status
History or presence of strabismus
Presence of amblyopia
Current or previous use of atropine and/or orthokeratology
Trial design
Design model
Single group
Treatments tested in this trial
More myopic eye: MCL1; Less myopic eye: MCL2
DeviceEach participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL1) and Myopia Control Lens 2 (MCL2) design, with one type of lens in each eye throughout the study period. MCL1 will be worn in the more myopic eye, and MCL2 in the less myopic eye for a period of 12 months.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: More myopic eye: MCL1; Less myopic eye: MCL2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in axial length difference between the eyes
Time frame
Base line, 12 months2
Change in cycloplegic spherical equivalent refraction between the eyes
Time frame
Baseline, 12 monthsSecondary outcomes
1
Change in axial length difference between the eyes
Time frame
Baseline, 6 monthsOther outcomes
1
Effect of baseline higher order aberrations on the change in axial length
Time frame
Baseline, 6 months, 12 months2
Effect of wearing compliance on the change in axial length
Time frame
Baseline, 6 months, 12 monthsSponsors and contacts
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Source ClinicalTrials.gov