Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405711
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-05
Brief Title:
To Evaluate the Efficacy and Safety of an Defocus Lens in Slowing the Progression of Myopia
Sponsor:
Tianjin Eye Hospital
Organization:
Tianjin Eye Hospital
Study Overview
Official Title:
To Evaluate the Efficacy and Safety of an Defocus Lens in Slowing the Progression of Myopiaa Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
To confirm the efficacy of DIMS lenses in controlling myopia progression we planned a prospective single-centre randomised double-blind controlled non-inferiority clinical study
Detailed Description:
Prior to the trial subjects signed an informed consent form screened and qualified subjects were enrolled and subjects received framed spectacles for correction of myopic refractive error in both eyes and were fitted with framed spectacles by the investigator according to the standard fitting procedure specified in this protocol Subjects were randomized to Trial Group A strong high order aberration group and Trial Group B medium high order aberration group and Control Group HOYA MiYOSMART
The index of effectiveness in this clinical trial was to assess the effectiveness of the test group of lenses in slowing the rate of myopia progression by examining the subjects objective optometric values after ciliary muscle paralysis The basic examination of this clinical trial included slit lamp examination eye axis examination fundus examination corneal topography best-corrected visual acuity binocular visual function refractive status and best-corrected visual acuity after ciliary muscle paralysis and intraocular pressure measurements etc The spectacle fitting was also recorded as well as the subjective feeling of the subjects when wearing the lenses
Each subject was followed up for 12 months and the efficacy and safety of the test product for delaying the progression of myopia was evaluated by the investigator at 1 week 1 day telephone follow-up 1 month 15 days telephone follow-up 3 months 15 days 6 months 15 days and 12 months 30 days after wearing the lenses
During the course of this clinical trial the lenses were replaced due to loss breakage change in refraction or poor vision with the lenses etc after evaluation by the investigator and the changes were recorded
The index of effectiveness in this clinical trial was to assess the effectiveness of the test group of lenses in slowing the rate of myopia progression by examining the subjects objective optometric values after ciliary muscle paralysis The basic examination of this clinical trial included slit lamp examination eye axis examination fundus examination corneal topography best-corrected visual acuity binocular visual function refractive status and best-corrected visual acuity after ciliary muscle paralysis and intraocular pressure measurements etc The spectacle fitting was also recorded as well as the subjective feeling of the subjects when wearing the lenses
Each subject was followed up for 12 months and the efficacy and safety of the test product for delaying the progression of myopia was evaluated by the investigator at 1 week 1 day telephone follow-up 1 month 15 days telephone follow-up 3 months 15 days 6 months 15 days and 12 months 30 days after wearing the lenses
During the course of this clinical trial the lenses were replaced due to loss breakage change in refraction or poor vision with the lenses etc after evaluation by the investigator and the changes were recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None