NCT04604405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

1 month

First QC Date

October 15, 2020

Last Update Submit

October 7, 2021

Conditions

Myopia

Keywords

photobiomodulation,macular microcirculation,,myopia

Outcome Measures

Primary Outcomes (3)

  • 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

  • retinal vascular perfusion

    The perfusion of the inner retinal layer in the macular area within 3×3mm was measured by angio-OCT

    12 weeks

  • Choroid thickness

    Distance from Bruch membrane to The inner surface of the sclera

    12 weeks

Secondary Outcomes (2)

  • Axial length

    12 weeks

  • diopter

    12 weeks

Study Arms (2)

photobiomodulation

EXPERIMENTAL

Eyes are irradiated with 650nm low energy red light

Radiation: photobiomodulation

blank

NO INTERVENTION

no intervention except for wear glasses

Interventions

photobiomodulationRADIATION

650nm low energy red light eye irradiation

photobiomodulation

Eligibility Criteria

Age7 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.);
  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chongqing Aier Eye Hosipital

Chongqing, Chongqing Municipality, 40000, China

Location

Related Publications (1)

  • 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.

    PMID: 39954097DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • yi wang, master

    Doctoral supervisor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor,Principal Investigator

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 27, 2020

Study Start

September 8, 2020

Primary Completion

October 9, 2020

Study Completion

October 2, 2021

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)