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

NCT05947019 | Unknown

• 1 other identifier: QX-2022-A-014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

High Myopia

Keywords

High Myopia; LLLT; Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes of equivalent spherical mirror after mydriatic optometry

  baseline, 180 days

Study Arms (2)

Low-Level Red-Light threapy plus glasses threapy

EXPERIMENTAL

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

Device: Myopic amblyopia comprehensive treatment instrument; Device: Glasses

glasses threapy

EXPERIMENTAL

conventional optometry with glasses for treatment

Device: Glasses

Interventions

Myopic amblyopia comprehensive treatment instrument DEVICE

Myopic amblyopia comprehensive treatment instrument is produced by Suzhou Industrial Park Zuoguan Medical Equipment Co., LTD.

Low-Level Red-Light threapy plus glasses threapy

Glasses DEVICE

Optometry with glasses as a routine treatment

Low-Level Red-Light threapy plus glasses threapy; glasses threapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Interventions

Eyeglasses

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• He Jiangnan, PhD

  Shanghai Eye Disease Prevention & Treatment Center

  STUDY DIRECTOR

Central Study Contacts

He Jiangnan

CONTACT

021-62539696; hejiangnan85@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: August 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)