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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06556849

Enrollment

Registered

2024-08-16

Start date

2020-12-01

Completion date

2024-06-30

Last updated

2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Interventions

DEVICEDefocus 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.

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
SE	36 months	spherical equivalent

Secondary

Measure	Time frame	Description
AL	36 months	axial lenght

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026