Effectiveness of DIMS Spectacle as a Function of the Age

NCT06556849 | Completed

• 1 other identifier: Myopia1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• SE

  spherical equivalent

  36 months

Secondary Outcomes (1)

• AL

  36 months

Study Arms (4)

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)

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)

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)

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)

Interventions

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.

Group A: patients oldest than 10 years that wear DIMS lens; Group B: patients oldest than 10 years that wear (control group); Group C: patients youngest than 10 years that wear DIMS lens; Group D: patients youngest than 10 years (control group)

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric patients with documented progressive myopiua

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Luca Buzzonetti: lead

Study Sites (1)

Luca Buzzonetti

Rome, Italy

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Luca Buzzonetti

  Bambino Gesù IRCCS Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Ophthalmology Unit

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 16, 2024
• Study Start: December 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

IT (1)