Status:
ACTIVE_NOT_RECRUITING
Comparison of Efficacy Between Two Myopia Control Lenses
Lead Sponsor:
Essilor International
Conditions:
Myopia
Eligibility:
All Genders
6-11 years
Phase:
NA
Brief 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 le...
Detailed Description
The clinical trial aims to assess the safety and efficacy of a test lens, designed to modify the amount of myopic control signal on the retina without compromising vision. The primary goal of this cli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06148870
Start Date
November 29 2023
End Date
April 1 2025
Last Update
February 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Essilor R&D Centre Singapore
Singapore, Singapore