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

October 7, 2021 updated by: jun ren, Central South University

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




Intervention / Treatment

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


Enrollment (Actual)



  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 45 years (Child, Adult)

Accepts Healthy Volunteers


Genders Eligible for Study



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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: photobiomodulation
Eyes are irradiated with 650nm low energy red light
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
The perfusion of the inner retinal layer in the macular area within 3×3mm was measured by angio-OCT
12 weeks
Choroid thickness
Time Frame: 12 weeks
Distance from Bruch membrane to The inner surface of the sclera
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


  • Study Director: yi wang, master, Doctoral supervisor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cq-wy-pbm-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?


Drug and device information, study documents

Studies a U.S. FDA-regulated drug product


Studies a U.S. FDA-regulated device product


This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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