MedDataX Logo

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

NCT ID: NCT04604405

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2021-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

photobiomodulation

Eyes are irradiated with 650nm low energy red light

Group Type EXPERIMENTAL

photobiomodulation

Intervention Type RADIATION

650nm low energy red light eye irradiation

blank

no intervention except for wear glasses

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

photobiomodulation

650nm low energy red light eye irradiation

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)
Minimum Eligible Age

7 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central South University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

jun ren

Attending doctor,Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

yi wang, master

Role: STUDY_DIRECTOR

Doctoral supervisor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chongqing Aier Eye Hosipital

Chongqing, Chongqing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Ren J, Xu JN, Liu YZ, Gu XL, Wang Y. Short-term effectiveness and safety of photobiomodulation on low-to-moderate myopia. Lasers Med Sci. 2025 Feb 15;40(1):95. doi: 10.1007/s10103-024-04119-7.

Reference Type DERIVED
PMID: 39954097 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

cq-wy-pbm-01

Identifier Type: -

Identifier Source: org_study_id