Clinical trial NCT04604405: Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation
Official title: Effect of 650nm Low Energy Light on Macular Microcirculation in Myopia Prevention and Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: photobiomodulation,macular microcirculation,,myopia
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 126
Sex: ALL
Minimum age (years): 7
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.)

Primary outcomes:
measure: retinal vascular density
timeFrame: 12 weeks
measure: retinal vascular perfusion
timeFrame: 12 weeks
measure: Choroid thickness
timeFrame: 12 weeks
Secondary outcomes:
measure: Axial length
timeFrame: 12 weeks
measure: diopter
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Aier Eye Hosipital
state: Chongqing
Study officials:
affiliation: Doctoral supervisor
name: yi wang, master
role: STUDY_DIRECTOR
References: