Efficacy of Repeated Low-Level Red-Light Therapy in Myopia Control

Myopia Clinical Trial

Official title:

The Clinical Trial of Myopia Control in Schoolchildren Using the Repeated Low-Level Red-Light Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04073238
• Other study ID #: 2019KYPJ093
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren.

Description:

Low level light therapy (LLLT) is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Its potential mechanisms of improving choroidal metabolic rate and circulation may improve scleral hypoxia, thus slowing down the progression of myopia. The investigator's preliminary case-series study suggested that repeated low-level red-light therapy was effective in slowing myopia progression without any clinically observable side effects. Using a randomized clinical trial design, the purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren. Study subjects will be randomly assigned to either the treatment group (receive repeated low-level red-light therapy) or the control group (wearing ordinary single vision lenses). Axial length and cycloplegic refraction will be monitored over one year (1st month, 3rd month, 6th month and 12th month), after which changes in axial length and refractive errors in the two groups will be compared. An interim analysis will be performed at the 3rd month, at which the data will be reported and presented. Appropriate adjustment of the p-value and decision on the continuation of the study will be made.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 264
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

1. Age at enrolment: 8-13 years

2. Spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D)

3. Astigmatism of 2.50 D or less

4. Anisometropia of 1.5 D or less

5. Spectacle corrected monocular logMAR visual acuity (VA): 0 or better

6. Parents' understanding and acceptance of random allocation of grouping

Exclusion Criteria:

1. Strabismus and binocular vision abnormalities in either eye

2. Ocular abnormalities in either eye or other systemic abnormalities

3. Prior treatment of myopia control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye

4. Other contraindications in either eye

Related Conditions & MeSH terms

• Eye Diseases
• Myopia
• Refractive Errors

Intervention

Device:
• Low-level Red-light Therapy
In addition to wearing single vision spectacle lens with power for correcting distance refraction, low-level red-light therapy is performed twice per school day at home with an interval of at least 4 hours, each treatment lasting 3 minutes.

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	The Second People's Hospital of Foshan	Foshan	Guangdong
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong
China	Shenzhen Children's Hospital	Shenzhen	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University	Shenzhen Children's Hospital, The Second People's Hospital of Foshan, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Axial length change (mm)	Axial length change (mm) is characterized as the difference between 2-year follow-up visit and baseline values. The IOLMaster is used to measure axial length (mm).	2 years
Other	Cycloplegic spherical equivalent change (Diopter)	Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between 2-year follow-up visit and baseline values. Cycloplegia is induced with one drop of Alcaine 0.5% followed by two drops of 1% cyclopentolate administered at 0, 5th to each eye. The third drop of cyclopentolate is used if the light reflex exists after 20 minute. The light reflex and pupil dilation is checked after an additional 15 minutes. Dilation and light reflex status is recorded and full cycloplegia is justified if the pupil dilates to 6 millimeters or greater and the light reflex is absent. Refraction is performed with an auto-refractor. The data on spherical and cylindrical power and axis is automatically extracted from the auto-refractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D).	2 years
Other	Visual acuity change	Visual acuity change is characterized as the difference between 2-year follow-up visit and baseline values. An ETDRS chart (Precision vision, Villa Park, Illinois, USA) with standard illumination is used to measure distance visual acuity. Visual acuity measurement is performed at a distance of 4 meters. Uncorrected visual acuity is measured for all children.	2 years
Other	Changes in other ocular parameters	The IOLMaster is used to measure ocular parameters (e.g., corneal curvature change). Change of each parameter is characterized as the difference between its 2-year follow-up visit and baseline values.	2 years
Other	Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.	2 years
Primary	Axial length change (mm)	Axial length change (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure axial length (mm).	1 month, 3 months, 6 months and 1 year
Secondary	Cycloplegic spherical equivalent change (Diopter)	Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Cycloplegia is induced with one drop of Alcaine 0.5% followed by two drops of 1% cyclopentolate administered at 0, 5th to each eye. The third drop of cyclopentolate is used if the light reflex exists after 20 minute. The light reflex and pupil dilation is checked after an additional 15 minutes. Dilation and light reflex status is recorded and full cycloplegia is justified if the pupil dilates to 6 millimeters or greater and the light reflex is absent. Refraction is performed with an auto-refractor. The data on spherical and cylindrical power and axis is automatically extracted from the auto-refractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D).	1 month, 3 months, 6 months and 1 year
Secondary	Corneal curvature change (mm)	Corneal curvature (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure corneal curvature (mm).	1 month, 3 months, 6 months and 1 year
Secondary	Anterior chamber depth change (mm)	Anterior chamber depth (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure anterior chamber depth (mm).	1 month, 3 months, 6 months and 1 year
Secondary	White to white change (mm)	White to white (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure white to white (mm).	1 month, 3 months, 6 months and 1 year
Secondary	Visual acuity change	Visual acuity change is characterized as the difference between each follow-up visit and baseline values. An ETDRS chart (Precision vision, Villa Park, Illinois, USA) with standard illumination is used to measure distance visual acuity. Visual acuity measurement is performed at a distance of 4 meters. Uncorrected visual acuity is measured for all children.	1 month, 3 months, 6 months and 1 year
Secondary	Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.	1 month
Secondary	Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.	3 months
Secondary	Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.	6 months
Secondary	Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.	1 year