NCT05840185

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression (DAL)

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression - DAL

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Accepted

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

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Test myopia control lenses (DAL)	A pair of myopia control spectacle lenses (test lenses) will be given to subjects to wear for 12 months

Timeline

• Start date: 2023-08-10
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-05-03
• Last updated: 2023-11-29

Locations

1 site across 1 country: Singapore