Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335212
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2022-12-26
Brief Title:
Peripheral Defocus Profile of Multifocal Minus Contact Lenses
Sponsor:
State University of New York College of Optometry
Organization:
State University of New York College of Optometry
Study Overview
Official Title:
Peripheral Defocus Profile of Multifocal Minus Contact Lenses
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose Numerous studies have proven that emmetropization in young animals including humans is regulated by visual input It has long been hypothesized that peripheral myopic defocus may act as a stop signal to reduce myopia progression and axial elongation As such multifocal soft contact lenses MFCLs have been utilized for myopia control in school-aged children with variable efficacies One potential explanation is that the actual peripheral myopic defocus an eye experiences during MFCL wear may not be identical to the Add power and not sufficient to reduce myopia progression Our study investigated and compared the peripheral power profiles of myopic eyes when they were uncorrected and wore single vision contact lenses SVCLs and MFCLs of different Add powers
Methods Subjects with -100 D to -1000 D of myopia SE determined with manifest refraction were custom fit with both single vision SV and MFCLs 200 and 400 D Add provided by Specialeyes in both eyes These Specialeyes MFCLs had an aspheric design with a standard total optical zone of 80mm Cycloplegic central autorefraction was conducted with both Grand Seiko WAM-5500 open-field auto-refractor Grand Seiko Co Ltd and OPD OPD-Scan III Wavefront Aberrometer Marco on the subjects in the following conditions 1 no CLs 2 SVCLs 3 MFCLs 200D Add and 4 MFCLs 400D Add Relative peripheral power profiles were measured using the OPD under the same 4 conditions after cycloplegia Data in the right eye was used for analysis
Methods Subjects with -100 D to -1000 D of myopia SE determined with manifest refraction were custom fit with both single vision SV and MFCLs 200 and 400 D Add provided by Specialeyes in both eyes These Specialeyes MFCLs had an aspheric design with a standard total optical zone of 80mm Cycloplegic central autorefraction was conducted with both Grand Seiko WAM-5500 open-field auto-refractor Grand Seiko Co Ltd and OPD OPD-Scan III Wavefront Aberrometer Marco on the subjects in the following conditions 1 no CLs 2 SVCLs 3 MFCLs 200D Add and 4 MFCLs 400D Add Relative peripheral power profiles were measured using the OPD under the same 4 conditions after cycloplegia Data in the right eye was used for analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None