Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression (NCT05331378) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression
Singapore80 participantsStarted 2022-04-25
Plain-language summary
This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.
Who can participate
Age range8 Years – 13 Years
SexALL
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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 8 years and not older than 13 years at time of informed consent and assent.
* Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
* Astigmatism, if present, of not more than 1.50 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 equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
* Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
* History of myopia control intervention
* Absence of strabismus by cover test at near or distance wearing correction.
* Absence of amblyopia
* Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
Exclusion Criteria
* Vulnerability of subject
* Participation in any clinical study within 30 days of the Baseline visit.
* Sibling of existing participant of this study