MyopiaNCT04604405

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

A study testing photobiomodulation in people with Myopia, run by Central South University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 7 to 45 years
Conditions the study is for: Myopia
What is being tested?: photobiomodulation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteChina
Study dates: 8 Sep 2020to 2 Oct 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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.;
Another eye with low vision
Corneal edema/epithelial detachment, corneal opacity;
Redness, pain, dry eye, photophobia, difficulty in opening eyes;
Had a history of eye surgery in recent 3 months;
Severe impairment of liver and kidney function and/or serious systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc.);

Show all 10Show fewer

Women who are already pregnant, preparing for pregnancy during the study period and lactating;
A history of substance abuse or alcohol abuse;
Receiving prevention and control treatment for myopia other than glasses within the first 30 days;
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.)

Trial locations and contacts

1 site in 1 country.

China1 site

Chongqing Aier Eye Hosipital
Chongqing, Chongqing Municipality, 40000

Other trials in China

About this study

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

Read the 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

Conditions: Myopia
Being tested: photobiomodulation
Keywords: photobiomodulation,macular microcirculation,,myopia
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

photobiomodulationRadiation
650nm low energy red light eye irradiation

Study groups in NCT04604405
Study group	Role	What they receive
photobiomodulation	Experimental	Eyes are irradiated with 650nm low energy red light Receives: Radiation: photobiomodulation
blank	No intervention	no intervention except for wear glasses

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Axial length
Distance from corneal apex to macular fovea
Measured: 12 weeks
diopter
Myopic degree
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 20202 Oct 2021

First posted27 Oct 2020
Study start8 Sep 2020
Primary completion9 Oct 2020
Study completion2 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04604405
Sponsor's protocol ID: cq-wy-pbm-01
Status last verified: Oct 2021
First submitted: 15 Oct 2020
Last updated: 15 Oct 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39954097

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of 650nm Low Energy Light on Macular Microcirculation in Myopia Prevention and Control
ClinicalTrials.gov ID: NCT04604405
Acronym / sponsor ID: cq-wy-pbm-01
Conditions: Myopia
Keywords: photobiomodulation,macular microcirculation,,myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Central South UniversityUniversity, hospital or other
Study start: 8 Sep 2020 (actual)
Primary completion: 9 Oct 2020 (actual)
Study completion: 2 Oct 2021 (actual)
First posted: 27 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
photobiomodulation	Experimental	Radiation: photobiomodulationEyes are irradiated with 650nm low energy red light
blank	No intervention	–no intervention except for wear glasses

Who may qualify

Ages: 7 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

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.;
Another eye with low vision
Corneal edema/epithelial detachment, corneal opacity;
Redness, pain, dry eye, photophobia, difficulty in opening eyes;
Had a history of eye surgery in recent 3 months;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
photobiomodulation650nm low energy red light eye irradiation	Radiation	photobiomodulation

Primary outcome

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
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
Choroid thickness
Time frame: 12 weeks
Distance from Bruch membrane to The inner surface of the sclera

2 secondary outcomes

Axial length
Time frame: 12 weeks
diopter
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
Derived from this study: PubMed 39954097Ren 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.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

yi wang, master study director

Doctoral supervisor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing photobiomodulation in people with Myopia, run by Central South University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

retinal vascular density (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04604405, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.