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

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ClinicalTrials.gov Identifier: NCT04073238
Recruitment Status : Active, not recruiting
First Posted : August 29, 2019
Last Update Posted : July 20, 2021
Sponsor:
Collaborators:
Shenzhen Children's Hospital
The Second People's Hospital of Foshan
Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Zhongshan Ophthalmic Center, Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Myopia Refractive Errors Eye Diseases Device: Low-level Red-light Therapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Trial of Myopia Control in Schoolchildren Using the Repeated Low-Level Red-Light Therapy
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Single vision spectacle lens
Single vision lens with power for correcting distance refraction.
Experimental: Repeated low-level red-light therapy
Single vision lens & repeated low-level red-light therapy
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.




Primary Outcome Measures :
  1. Axial length change (mm) [ Time Frame: 1 month, 3 months, 6 months and 1 year ]
    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).


Secondary Outcome Measures :
  1. Cycloplegic spherical equivalent change (Diopter) [ Time Frame: 1 month, 3 months, 6 months and 1 year ]
    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).

  2. Corneal curvature change (mm) [ Time Frame: 1 month, 3 months, 6 months and 1 year ]
    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).

  3. Anterior chamber depth change (mm) [ Time Frame: 1 month, 3 months, 6 months and 1 year ]
    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).

  4. White to white change (mm) [ Time Frame: 1 month, 3 months, 6 months and 1 year ]
    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).

  5. Visual acuity change [ Time Frame: 1 month, 3 months, 6 months and 1 year ]
    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.

  6. Incidence of treatment-emergent adverse events [ Time Frame: 1 month ]
    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.

  7. Incidence of treatment-emergent adverse events [ Time Frame: 3 months ]
    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.

  8. Incidence of treatment-emergent adverse events [ Time Frame: 6 months ]
    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.

  9. Incidence of treatment-emergent adverse events [ Time Frame: 1 year ]
    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.


Other Outcome Measures:
  1. Axial length change (mm) [ Time Frame: 2 years ]
    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. Cycloplegic spherical equivalent change (Diopter) [ Time Frame: 2 years ]
    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).

  3. Visual acuity change [ Time Frame: 2 years ]
    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.

  4. Changes in other ocular parameters [ Time Frame: 2 years ]
    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.

  5. Incidence of treatment-emergent adverse events [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073238


Locations
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China, Guangdong
The Second People's Hospital of Foshan
Foshan, Guangdong, China, 528000
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518038
China, Hunan
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410008
Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Shenzhen Children's Hospital
The Second People's Hospital of Foshan
Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Mingguang He, Professor Zhongshan Ophthalmic Center, Sun Yat-sen University
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Responsible Party: Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04073238    
Other Study ID Numbers: 2019KYPJ093
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Eye Diseases
Refractive Errors