Skip to main content
OpenTrials
Completed

NCT Number: NCT04604405

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chongqing Aier Eye Hosipital

Chongqing, Chongqing Municipality, 40000, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.)

Treatment and study plan

Photobiomodulation

Radiation

650nm low energy red light eye irradiation

Primary outcomes

  1. 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

  2. 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

  3. Choroid thickness

    Time frame: 12 weeks

    Distance from Bruch membrane to The inner surface of the sclera

Secondary outcomes

  1. Axial length

    Time frame: 12 weeks

    Distance from corneal apex to macular fovea

  2. diopter

    Time frame: 12 weeks

    Myopic degree

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 27, 2020
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.