Effectiveness of Defocus Incorporated Multiple Segments in Slowing Myopia Progression as a Function of the Age in Pediatric Patients. Three Years Follow up.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- SE
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 6 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
SE
Time Frame: 36 months
spherical equivalent
Secondary Outcomes
- AL(36 months)
Investigators
Luca Buzzonetti
Head of Ophthalmology Unit
Bambino Gesù Hospital and Research Institute