Comparison of Efficacy Between Two Myopia Control Lenses (NCT06148870) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Efficacy Between Two Myopia Control Lenses
Singapore50 participantsStarted 2023-11-29
Plain-language summary
This is a one-year, mono-centre, randomize, double-masked, monocular cross-over clinical trial designed to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopia progression.
Who can participate
Age range6 Years – 11 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form.
* Equal to or greater than 6 years and not older than 11 years at time of informed consent and assent.
* Spherical equivalent refractive error (SER) by manifest refraction between -0.50 and -4.75 D in each eye.
* Astigmatism, if present, of not more than 2.00 D.
* Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
* Best corrected visual acuity in each eye better than +0.20 logMAR
* Agree to wear study spectacles for at least 10 hours a day and 6 days a week
* Willingness and ability to participate in trial for 1 year
* Willingness and ability to attend scheduled visits
* Not to involve concurrently in other myopia control treatments
Exclusion Criteria:
* History or presence of an Ocular disease, Strabismus, Amblyopia
* Undergoing any myopia control intervention specifically Atropine and Orthokeratology
* History of myopia control intervention specifically Atropine, Orthokeratology