NCT06556849

Effectiveness of DIMS Spectacle as a Function of the Age

Effectiveness of Defocus Incorporated Multiple Segments in Slowing Myopia Progression as a Function of the Age in Pediatric Patients. Three Years Follow up.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Luca Buzzonetti · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

Purpose: To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients. Methods: This was a non-randomized experimenter-masked retrospective controlled observational study of European individuals aged 6 -16 years with progressive myopia but no ocular pathology. The charts of the participants allocated to receive DIMS spectacles (Hoya® MiyoSmart®) or single vision spectacle lenses (control group) were retrospectively reviewed. The key outcome variables, cycloplegic spherical equivalent (SE) and axial length (AL), were measured at baseline and at 36 month follow up. The results were stratified by age into four groups: patients that wore DIMS spectacles oldest or youngest than 10 years (respectively, group A, 20 patients mean age 13.6±2.2 and group C, 20 patients mean age 9.0±1.2) and age matched control groups (group B, 18 patients mean age 13.2±2.5 and group D, mean age 8.5±0.9).

Detailed description

Participants were allocated to the study groups, receiving DIMS spectacles, or to the control groups, wearing single vision spectacle lenses.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Defocus Incorporated Multiple Segments (DIMS)	To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.

Timeline

• Start date: 2020-12-01
• Primary completion: 2020-12-01
• Completion: 2024-06-30
• First posted: 2024-08-16
• Last updated: 2024-08-20

Locations

1 site across 1 country: Italy