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

Primary Purpose

High Myopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Myopic amblyopia comprehensive treatment instrument
Glasses
Sponsored by
Shanghai Eye Disease Prevention and Treatment Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Myopia focused on measuring High Myopia; LLLT; Adults

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18 and 40 years, regardless of gender. 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. Normal cognitive abilities and language communication skills, capable of actively cooperating with the required treatment. Absence of contraindications for atropine use, such as acute ocular inflammation, dry eye, keratoconus, and diabetes. Written informed consent obtained from the patients. Exclusion Criteria: History of photoallergy, glaucoma, trichiasis syndrome, ocular hypertension, fundus macula lesions, or eye injuries. Corneal curvature examination revealing an average K value of the anterior corneal surface of ≥45. Presence of systemic diseases (e.g., heart, liver, kidney diseases) and congenital hereditary myopia. Chronic eye diseases, including ocular trauma, strabismus, or previous ocular surgery, as well as allergic conjunctivitis. Previous internal trichiasis, severe corneal opacity, conjunctival infection, or other eye diseases. Neurological diseases, allergies, or contraindications to atropine or other therapeutic drugs. Presence of immune system and systemic diseases such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, or diabetes. Epilepsy or mental disorders that hinder normal communication. 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. Any other situation deemed unsuitable for participation in the study by the researcher.

Sites / Locations

  • Shanghai Eye Disease Prevention & Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low-Level Red-Light threapy plus glasses threapy

glasses threapy

Arm Description

Myopic amblyopia comprehensive treatment equipment + conventional optometry with glasses for treatment

conventional optometry with glasses for treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 7, 2023
Last Updated
July 7, 2023
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
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1. Study Identification

Unique Protocol Identification Number
NCT05947019
Brief Title
Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults
Official Title
Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults: A Randomized, Controlled, Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia
Keywords
High Myopia; LLLT; Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Level Red-Light threapy plus glasses threapy
Arm Type
Experimental
Arm Description
Myopic amblyopia comprehensive treatment equipment + conventional optometry with glasses for treatment
Arm Title
glasses threapy
Arm Type
Experimental
Arm Description
conventional optometry with glasses for treatment
Intervention Type
Device
Intervention Name(s)
Myopic amblyopia comprehensive treatment instrument
Intervention Description
Myopic amblyopia comprehensive treatment instrument is produced by Suzhou Industrial Park Zuoguan Medical Equipment Co., LTD.
Intervention Type
Device
Intervention Name(s)
Glasses
Intervention Description
Optometry with glasses as a routine treatment
Primary Outcome Measure Information:
Title
Change from baseline in axial length of the left and right eyes
Description
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.
Time Frame
baseline, 30days, 90 days, 180 days
Secondary Outcome Measure Information:
Title
Changes of equivalent spherical mirror after mydriatic optometry
Description
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.
Time Frame
baseline, 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 40 years, regardless of gender. 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. Normal cognitive abilities and language communication skills, capable of actively cooperating with the required treatment. Absence of contraindications for atropine use, such as acute ocular inflammation, dry eye, keratoconus, and diabetes. Written informed consent obtained from the patients. Exclusion Criteria: History of photoallergy, glaucoma, trichiasis syndrome, ocular hypertension, fundus macula lesions, or eye injuries. Corneal curvature examination revealing an average K value of the anterior corneal surface of ≥45. Presence of systemic diseases (e.g., heart, liver, kidney diseases) and congenital hereditary myopia. Chronic eye diseases, including ocular trauma, strabismus, or previous ocular surgery, as well as allergic conjunctivitis. Previous internal trichiasis, severe corneal opacity, conjunctival infection, or other eye diseases. Neurological diseases, allergies, or contraindications to atropine or other therapeutic drugs. Presence of immune system and systemic diseases such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, or diabetes. Epilepsy or mental disorders that hinder normal communication. 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. Any other situation deemed unsuitable for participation in the study by the researcher.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Jiangnan
Phone
021-62539696
Email
hejiangnan85@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Jiangnan, PhD
Organizational Affiliation
Shanghai Eye Disease Prevention & Treatment Center
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Eye Disease Prevention & Treatment Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Jiangnan, PhD
Phone
021-62539696
Email
hejiangnan85@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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