Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation

Sponsor

Central South University (Other)

Overall Status

Completed

CT.gov ID

NCT04604405

Collaborator

(none)

126

Enrollment

Location

Arms

12.8

Actual Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Radiation: photobiomodulation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of 650nm Low Energy Light on Macular Microcirculation in Myopia Prevention and Control

Actual Study Start Date :

Sep 8, 2020

Actual Primary Completion Date :

Oct 9, 2020

Actual Study Completion Date :

Oct 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: photobiomodulation Eyes are irradiated with 650nm low energy red light	Radiation: photobiomodulation 650nm low energy red light eye irradiation
No Intervention: blank no intervention except for wear glasses

Arm

Intervention/Treatment

Experimental: photobiomodulation

Eyes are irradiated with 650nm low energy red light

Radiation: photobiomodulation

650nm low energy red light eye irradiation

No Intervention: blank

no intervention except for wear glasses

Outcome Measures

Primary Outcome Measures

retinal vascular density [12 weeks]
The vascular density of the inner retinal layer in the macular area within 3×3mm was measured by angio-OCT
retinal vascular perfusion [12 weeks]
The perfusion of the inner retinal layer in the macular area within 3×3mm was measured by angio-OCT
Choroid thickness [12 weeks]
Distance from Bruch membrane to The inner surface of the sclera

Secondary Outcome Measures

Axial length [12 weeks]
Distance from corneal apex to macular fovea
diopter [12 weeks]
Myopic degree

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age from 7 to 17 years old or from 18 to 45 years old;
Meet the diagnostic criteria for patients with simple low or moderate myopia, with diopter < -6.0d and eye axis < 26.0mm;
Transparent refractive stroma, no other eye diseases except nearsightedness;
Agree to participate in the clinical study and sign the informed consent.

Exclusion Criteria:

Other ocular lesions, such as uveitis, retinal/choroidal vascular lesions, congenital ocular lesions, glaucoma, high myopia (ocular axis > 26cm), degenerative retinal disease, optic neuropathy, etc.;
Another eye with low vision
Corneal edema/epithelial detachment, corneal opacity;
Redness, pain, dry eye, photophobia, difficulty in opening eyes;
Had a history of eye surgery in recent 3 months;
Severe impairment of liver and kidney function and/or serious systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc.);
Women who are already pregnant, preparing for pregnancy during the study period and lactating;
A history of substance abuse or alcohol abuse;
Receiving prevention and control treatment for myopia other than glasses within the first 30 days;
Any situation in which the study physician believes that the patient's condition will interfere with the clinical study (e.g., the patient is prone to nervous tension, uncontrollable emotions, depression, etc.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chongqing Aier Eye Hosipital	Chongqing	Chongqing	China	40000

Sponsors and Collaborators

Central South University

Investigators

Study Director: yi wang, master, Doctoral supervisor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

jun ren, Attending doctor,Principal Investigator, Central South University

ClinicalTrials.gov Identifier:

NCT04604405

Other Study ID Numbers:

cq-wy-pbm-01

First Posted:

Oct 27, 2020

Last Update Posted:

Oct 15, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by jun ren, Attending doctor,Principal Investigator, Central South University

photobiomodulation,macular microcirculation,,myopia

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Oct 15, 2021