Effectiveness of DIMS Spectacle as a Function of the Age

Completed

• Conditions: Myopia

• Registration Number: NCT06556849
• Lead Sponsor: Luca Buzzonetti

Brief 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.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2020-12-01
• Study Completion: 2024-06-30
• Study First Submitted: 2024-07-19
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• patient age between 6-16 years
• progressive myopia with cycloplegic spherical equivalent (SE) from -0.50 to -4.00 diopters (D)
• astigmatism less than 2.50D, anisometropia under 1.25D

Exclusion Criteria

• genetic syndromes suspected (e.g., Stickler, Marfan, etc.)
• systemic diseases
• eye diseases (such as glaucoma, juvenile cataracts, retinal abnormalities, any form of strabismus)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SE	36 months	spherical equivalent

Secondary Outcome Measures

Name	Time	Method
AL	36 months	axial lenght

Trial Locations

Locations (1)

Luca Buzzonetti; 🇮🇹 Rome, Italy