Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556849
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Effectiveness of DIMS Spectacle as a Function of the Age
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 13622 and group C 20 patients mean age 9012 and age matched control groups group B 18 patients mean age 13225 and group D mean age 8509
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 13622 and group C 20 patients mean age 9012 and age matched control groups group B 18 patients mean age 13225 and group D mean age 8509
Detailed Description:
Participants were allocated to the study groups receiving DIMS spectacles or to the control groups wearing single vision spectacle lenses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None