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

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Radiation: photobiomodulation

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 Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 40000
      • Chongqing Aier Eye Hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.;
2. Another eye with low vision
3. Corneal edema/epithelial detachment, corneal opacity;
4. Redness, pain, dry eye, photophobia, difficulty in opening eyes;
5. Had a history of eye surgery in recent 3 months;
6. Severe impairment of liver and kidney function and/or serious systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc.);
7. Women who are already pregnant, preparing for pregnancy during the study period and lactating;
8. A history of substance abuse or alcohol abuse;
9. Receiving prevention and control treatment for myopia other than glasses within the first 30 days;
10. 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Distance from corneal apex to macular fovea	12 weeks
diopter	Myopic degree	12 weeks

Collaborators and Investigators

• Sponsor: Central South University
• Investigators: Study Director: yi wang, master, Doctoral supervisor

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): October 9, 2020
• Study Completion (Actual): October 2, 2021

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: photobiomodulation,macular microcirculation,,myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: cq-wy-pbm-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No