Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604405
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2020-10-15
Brief Title:
Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation
Sponsor:
Central South University
Organization:
Central South University
Study Overview
Official Title:
Effect of 650nm Low Energy Light on Macular Microcirculation in Myopia Prevention and Control
Status:
COMPLETED
Status Verified Date:
2021-10
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:
This project is a single-center prospective self-controlled clinical study It intends to select patients with simple medium and low degree myopia as subjects and apply 650nm low-energy red light irradiation to the retina to observe its effect on macular microcirculation
Detailed Description:
A total of 120 subjects are planned to be recruited and divided into 4 groups according to age and intervention including 30 in the juvenile intervention group 30 in the juvenile control group 30 in the adult intervention group and 30 in the adult control group Two intervention groups received 650nm low-energy red light irradiation treatment with a 650nm low-energy light emitter twice a day for 3 minutes each time The subjects were treated and followed up for 3 months The control group was not treated and followed up for 3 months too All subjects were followed up before treatment at the end of the 1st month and at the end of 3rd month Angio-oct was used as the main examination to observe and record the vascular density and blood perfusion in macular area Axial length diopter and OCT were used as secondary observation indexes At the end of the experiment the data of the intervention group and the control group were compared
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