Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression - DAL
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Essilor International
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Axial Length
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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
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 to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial (Bao et al. 2022). A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy. This open clinical trial will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (40 subjects) at the time of commencing treatment. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuities will also be compared between test lenses and control lenses of the historical control group to determine the quality of vision using test lenses
Investigators
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 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
- •History of myopia control intervention
- •Participation in any clinical study within 30 days of the Baseline visit.
Outcomes
Primary Outcomes
Axial Length
Time Frame: 12 months
Change in ocular axial length (mm) measured using Lenstar Optical Biometer.
Secondary Outcomes
- Spherical Equivalent Refraction(6 months and 12 months)