Skip to main content
OpenTrials
Completed

NCT Number: NCT06556849

Effectiveness of DIMS Spectacle as a Function of the Age

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Luca Buzzonetti

Rome, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Defocus Incorporated Multiple Segments (DIMS)

Device

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

Primary outcomes

  1. SE

    Time frame: 36 months

    spherical equivalent

Secondary outcomes

  1. AL

    Time frame: 36 months

    axial lenght

Sponsors and collaborators

Lead sponsor

Luca Buzzonetti

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2024
First posted
Aug 16, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.