Status:
ACTIVE_NOT_RECRUITING
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression
Lead Sponsor:
Essilor International
Conditions:
Myopia, Progressive
Myopia
Eligibility:
All Genders
8-13 years
Phase:
NA
Brief 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 elongat...
Detailed Description
As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05331378
Start Date
April 25 2022
End Date
October 1 2025
Last Update
August 7 2025
Active Locations (1)
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1
Essilor R&D Centre Singapore
Singapore, Singapore, 339346