Targeted Lens Intervention for Myopic Anisometropia in Children

Clinical Investigation of Targeted Lens Intervention in the Management of Myopic Anisometropia in Children

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

Inclusion Criteria:

1. Voluntary
2. Informed consent of parent/guardian and assent of participant
3. Age equal to or greater than 6 years old and less than 13 years at the time of signing informed consent and assent
4. SER equal or less than -0.50 D and equal or greater than .5.00 D with astigmatism not more than 2.50 D
5. Difference in SER (anisometropia) between two eyes .1.00 D
6. Best corrected visual acuity (BCVA) better than or equal to +0.20 LogMAR in each eye
7. Agree to wear study spectacles for .12 hours/day and 7 days/week
8. Willingness and ability to participate in investigation for 12 months and attend scheduled visits punctually
9. Agree for no concurrent involvement in other myopia control treatment

Exclusion Criteria:

1. History or presence of an ocular disease affecting refractive status
2. History or presence of strabismus
3. Presence of amblyopia
4. Current or previous use of atropine and/or orthokeratology
5. Known allergy to cycloplegic agents
6. Contraindication to cycloplegic agents
7. Cognitive or psychological vulnerability