Targeted Lens Intervention for Myopic Anisometropia 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 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
Qualifiers
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
Treatments tested in this trial
- More myopic eye: MCL1; Less myopic eye: MCL2
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov