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NCT05724186
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression (CSL)
Conditions: Myopia
Sex: All
Ages: 8 Years – 13 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 40
Sponsor: Essilor International
Location: Singapore
Summary
This is a mono-centre, prospective, one-arm, unmask clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation compared to a single vision spectacle lens from the historical control group of another clinical trial NCT05331378.
A total of 40 children will be recruited.
Eligibility Criteria
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.8 to 13 years old 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.Absence of strabismus by cover test at near or distance wearing correction.Absence of amblyopiaWithout ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.Exclusion Criteria:Vulnerability of subjectHistory of myopia control interventionParticipation in any clinical study within 30 days of the Baseline visit.
Source: ClinicalTrials.gov (NCT05724186). StuddyBuddy aggregates publicly available trial information.