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.

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).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Defocus Incorporated Multiple Segments (DIMS)

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Luca Buzzonetti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

pediatric patients with documented progressive myopiua

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A: patients oldest than 10 years that wear DIMS lens; myopic patients oldest than 10 years of age that wore Defocus Incorporated Multiple Segments (DIMS) spectacles	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.
Group B: patients oldest than 10 years that wear (control group); myopic patients oldest than 10 years of age that wore single vision spectacle lenses (control group)	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.
Group C: patients youngest than 10 years that wear DIMS lens; myopic patients youngest than 10 years of age that wore Defocus Incorporated Multiple Segments (DIMS) spectacles	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.
Group D: patients youngest than 10 years (control group); myopic patients youngest than 10 years of age that wore single vision spectacle lenses (control group)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SE	spherical equivalent	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AL	axial lenght	36 months

Collaborators and Investigators

• Sponsor: Luca Buzzonetti
• Investigators: Principal Investigator: Luca Buzzonetti, Bambino Gesù IRCCS Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: Myopia1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No