Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults

Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults: A Randomized, Controlled, Multicenter Clinical Trial

The purpose of this clinical study is to confirm the effectiveness and safety of low-level monochromatic red-light for high myopia control in adults

Study Overview

• Status: Not yet recruiting
• Conditions: High Myopia
• Intervention / Treatment: Device: Myopic amblyopia comprehensive treatment instrument; Device: Glasses

Detailed Description

Currently, there is still a lack of effective methods for managing adult high myopia globally. The Elsing Myopia and Amblyopia Therapy Instrument, developed by Suzhou Industrial Park Zuoguan Medical Equipment Co., Ltd., has gained widespread usage in mainland China for amblyopia treatment and myopia control. This instrument utilizes low-intensity laser therapy (LLLT) for treatment, demonstrating improvements in visual acuity without any local or systemic side effects. The low-intensity laser induces photochemical reactions in the retina, such as enhancing cytochrome C oxidase activity, modulating gene expression to regulate the mitochondrial respiratory chain, and increasing the biological activity of nitric oxide. These mechanisms have been applied in the treatment of age-related macular degeneration and diabetic retinopathy. As the onset of myopia is closely linked to retinal signaling pathways, preliminary test data suggests that the instrument can significantly slow down myopia progression. This study aims to investigate the potential of low-intensity laser therapy in preventing and treating high myopia in adults, providing innovative approaches to mitigate the widespread impact of high myopia.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: He Jiangnan; Phone Number: 021-62539696; Email: hejiangnan85@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Shanghai Eye Disease Prevention & Treatment Center
      • Contact: He Jiangnan, PhD; Phone Number: 021-62539696; Email: hejiangnan85@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 18 and 40 years, regardless of gender.
2. Presence of myopic refractive error in at least one eye, with myopic lens power after mydriasis exceeding 6.00D, diffusivity less than 2.00D, binocular anisometropia less than 3.00D, and best corrected distance visual acuity of at least 0.6, as well as near visual acuity of at least 0.6.
3. Normal cognitive abilities and language communication skills, capable of actively cooperating with the required treatment.
4. Absence of contraindications for atropine use, such as acute ocular inflammation, dry eye, keratoconus, and diabetes.
5. Written informed consent obtained from the patients.

Exclusion Criteria:

1. History of photoallergy, glaucoma, trichiasis syndrome, ocular hypertension, fundus macula lesions, or eye injuries.
2. Corneal curvature examination revealing an average K value of the anterior corneal surface of ≥45.
3. Presence of systemic diseases (e.g., heart, liver, kidney diseases) and congenital hereditary myopia.
4. Chronic eye diseases, including ocular trauma, strabismus, or previous ocular surgery, as well as allergic conjunctivitis.
5. Previous internal trichiasis, severe corneal opacity, conjunctival infection, or other eye diseases.
6. Neurological diseases, allergies, or contraindications to atropine or other therapeutic drugs.
7. Presence of immune system and systemic diseases such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, or diabetes.
8. Epilepsy or mental disorders that hinder normal communication.
9. Previous use of other treatments to control myopia progression, such as anticholinergic drugs like atropine within the past 3 months, or participation in other studies involving functional frame lenses, multifocal soft lenses, or similar interventions.
10. Any other situation deemed unsuitable for participation in the study by the researcher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Level Red-Light threapy plus glasses threapy; Myopic amblyopia comprehensive treatment equipment + conventional optometry with glasses for treatment	Device: Myopic amblyopia comprehensive treatment instrument; Myopic amblyopia comprehensive treatment instrument is produced by Suzhou Industrial Park Zuoguan Medical Equipment Co., LTD.; Device: Glasses; Optometry with glasses as a routine treatment
Experimental: glasses threapy; conventional optometry with glasses for treatment	Device: Glasses; Optometry with glasses as a routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in axial length of the left and right eyes	The axis of the eye was assessed utilizing the IOL Master (version 5.02, Carl Zeiss, Jena, Germany), which employed simulated eye calibration prior to measurements. To ensure accuracy, three consecutive measurements were taken, and the average value was obtained. If the difference between any two measurements exceeded 0.05mm, a re-measurement was performed.	baseline, 30days, 90 days, 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of equivalent spherical mirror after mydriatic optometry	Based on previous experience, this instrument requires a treatment duration of 180 days to demonstrate its preventive and control effects. Therefore, the 180-day data changes will be utilized as the evaluation indicator.	baseline, 180 days

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Study Director: He Jiangnan, PhD, Shanghai Eye Disease Prevention & Treatment Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: High Myopia; LLLT; Adults
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: QX-2022-A-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No