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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04604405
• Other study ID #: cq-wy-pbm-01
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: October 2, 2021

Study information

• Verified date: October 2021
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2, 2021
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 45 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Myopia

Intervention

Radiation:
• photobiomodulation
650nm low energy red light eye irradiation

Locations

Country	Name	City	State
China	Chongqing Aier Eye Hosipital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	retinal vascular perfusion	The perfusion of the inner retinal layer in the macular area within 3×3mm was measured by angio-OCT	12 weeks
Primary	Choroid thickness	Distance from Bruch membrane to The inner surface of the sclera	12 weeks
Secondary	Axial length	Distance from corneal apex to macular fovea	12 weeks
Secondary	diopter	Myopic degree	12 weeks