Back to results

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

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

photobiomodulation

About this trial

This is an interventional treatment trial for Myopia focused on measuring photobiomodulation,macular microcirculation,,myopia

Eligibility Criteria

7 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Chongqing Aier Eye Hosipital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

photobiomodulation

blank

Arm Description

Eyes are irradiated with 650nm low energy red light

no intervention except for wear glasses

Outcomes

Primary Outcome Measures

retinal vascular density

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

retinal vascular perfusion

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

Choroid thickness

Distance from Bruch membrane to The inner surface of the sclera

Secondary Outcome Measures

Axial length

Distance from corneal apex to macular fovea

diopter

Myopic degree

Full Information

NCT ID

NCT04604405

First Posted

October 15, 2020

Last Updated

October 7, 2021

Sponsor

Central South University

1. Study Identification

Unique Protocol Identification Number

NCT04604405

Brief Title

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

September 8, 2020 (Actual)

Primary Completion Date

October 9, 2020 (Actual)

Study Completion Date

October 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

Keywords

photobiomodulation,macular microcirculation,,myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

photobiomodulation

Arm Type

Experimental

Arm Description

Eyes are irradiated with 650nm low energy red light

Arm Title

blank

Arm Type

No Intervention

Arm Description

no intervention except for wear glasses

Intervention Type

Radiation

Intervention Name(s)

photobiomodulation

Intervention Description

650nm low energy red light eye irradiation

Primary Outcome Measure Information:

Title

retinal vascular density

Description

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

Time Frame

12 weeks

Title

retinal vascular perfusion

Description

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

Time Frame

12 weeks

Title

Choroid thickness

Description

Distance from Bruch membrane to The inner surface of the sclera

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Axial length

Description

Distance from corneal apex to macular fovea

Time Frame

12 weeks

Title

diopter

Description

Myopic degree

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yi wang, master

Organizational Affiliation

Doctoral supervisor

Official's Role

Study Director

Facility Information:

Facility Name

Chongqing Aier Eye Hosipital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

40000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs