Efficacy of Repeated Low-level Red-light Therapy in Myopia Control
Study Details
Study Description
Brief Summary
Low-level red-light technology provides a new and innovative myopia control approach. This strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. The efficacy of the low-level red-light technology has been proven in a Chinese population. This trial demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. Repeating this RCT in culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to assess the safety and efficacy of low level red light therapy in myopia control in African, Hispanic, and Caucasian children. This is a prospective, multi-ethnic, parallel-controlled randomized trial that will enroll myopic children aged 8-13 years old as subjects. On top of wearing single vision spectacles, subjects in the intervention group will receive treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours. Subjects in the control group will wear single vision spectacles. The study will evaluate axial elongation, cycloplegic spherical equivalent change, changes in other biological parameters (except axial length), and uncorrected and best corrected visual acuity of the two groups of subjects at 1 month, 3 months, 6 months, and 12 months after enrollment. The study plans to conduct an interim analysis at a three-month follow-up. The enrollment target is 90 participants: 30 Hispanic Children (15 control and 15 treatment) , 30 African Children (15 control and 15 treatment), and 30 Caucasian Children (15 control and 15 treatment).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low Level Red Light Treatment Arm On top of wearing single vision spectacles, subjects in the intervention group will receive low-level red light treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours. |
Device: Low-level Red Light Therapy Device
The treatment device used in this study is a semi-conductor laser product (Eyerising International Pty Ltd, Melbourne, Australia), emitting low-level red-light with a wavelength of 650 ± 10 nm. Based on calculations done by the manufacturer, the device provides light at a power of 2.00 ± 0.50 mW.
|
| No Intervention: Control Treatment Arm Subjects in the control group will wear single vision spectacles. |
Outcome Measures
Primary Outcome Measures
- Axial Length (AL) (mm) at Baseline [1 month]
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
- Axial Length (AL) (mm) at Month 1 [1 month]
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
- Axial Length (AL) (mm) at Month 3 [3 months]
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
- Axial Length (AL) (mm) at Month 6 [6 months]
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
- Axial Length (AL) (mm) at Year 1 [1 Year]
Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.
Secondary Outcome Measures
- Spherical Equivalent Refraction (SER) (Diopter) at Baseline [Baseline]
Spherical equivalent (Diopter, D) is the spherical power plus half of the cylindrical power. 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. This will be taken at 1-,3-, 6-, and 12-month follow-up visits.
- Spherical Equivalent Refraction (SER) (Diopter) at Month 1 [1 month]
Spherical equivalent (Diopter, D) is the spherical power plus half of the cylindrical power. 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. This will be taken at 1-,3-, 6-, and 12-month follow-up visits.
- Spherical Equivalent Refraction (SER) (Diopter) at Month 3 [3 months]
Spherical equivalent (Diopter, D) is the spherical power plus half of the cylindrical power. 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. This will be taken at 1-,3-, 6-, and 12-month follow-up visits.
- Spherical Equivalent Refraction (SER) (Diopter) at Month 6 [6 months]
Spherical equivalent (Diopter, D) is the spherical power plus half of the cylindrical power. 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. This will be taken at 1-,3-, 6-, and 12-month follow-up visits.
- Spherical Equivalent Refraction (SER) (Diopter) at Year 1 [1 year]
Spherical equivalent (Diopter, D) is the spherical power plus half of the cylindrical power. 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. This will be taken at 1-,3-, 6-, and 12-month follow-up visits.
- Corneal radius of curvature (CC) at Baseline [Baseline]
Corneal radius of curvature (CC) is taken and characterized with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. CC will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- Corneal radius of curvature (CC) at Month 1 [1 month]
Corneal radius of curvature (CC) is taken and characterized with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. CC will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- Corneal radius of curvature (CC) at Month 3 [3 months]
Corneal radius of curvature (CC) is taken and characterized with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. CC will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- Corneal radius of curvature (CC) at Month 6 [6 months]
Corneal radius of curvature (CC) is taken and characterized with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. CC will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- Corneal radius of curvature (CC) at Year 1 [1 year]
Corneal radius of curvature (CC) is taken and characterized with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. CC will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- Anterior Chamber Depth (ACD) at Baseline [Baseline]
Anterior chamber depth (ACD) is characterized as measures of taken with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. ACD will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- Anterior Chamber Depth (ACD) at Month 1 [1 month]
Anterior chamber depth (ACD) is characterized as measures of taken with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. ACD will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- Anterior Chamber Depth (ACD) at Month 3 [3 months]
Anterior chamber depth (ACD) is characterized as measures of taken with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. ACD will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- Anterior Chamber Depth (ACD) at Month 6 [6 months]
Anterior chamber depth (ACD) is characterized as measures of taken with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. ACD will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- Anterior Chamber Depth (ACD) at Year 1 [1 year]
Anterior chamber depth (ACD) is characterized as measures of taken with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. ACD will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- White-to-White (WTW) at Baseline [Baseline]
White to white (mm) is characterized as measures taken with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. as the difference between each follow-up visit and baseline values. White-to-white (WTW) measurements will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- White-to-White (WTW) at Month 1 [1 month]
White to white (mm) is characterized as measures taken with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. as the difference between each follow-up visit and baseline values. White-to-white (WTW) measurements will be taken at the 1-,3-, 6-, and 12-month follow-up visits. as the difference between each follow-up visit and baseline values. White-to-white (WTW) measurements will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- White-to-White (WTW) at Month 3 [3 months]
White to white (mm) is characterized as measures taken with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. as the difference between each follow-up visit and baseline values. White-to-white (WTW) measurements will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- White-to-White (WTW) at Month 6 [6 months]
White to white (mm) is characterized as measures taken with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. as the difference between each follow-up visit and baseline values. White-to-white (WTW) measurements will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- White-to-White (WTW) at Year 1 [1 year]
White to white (mm) is characterized as measures taken with an IOLMaster which is an ocular biometric measurement instrument that uses the principle of partial coherence interferometry (PCI) to perform non-contact ocular biometric measurements. as the difference between each follow-up visit and baseline values. White-to-white (WTW) measurements will be taken at the 1-,3-, 6-, and 12-month follow-up visits.
- Undercorrected Visual Acuity at Baseline [Baseline]
Undercorrected Visual Acuity is characterized by line-by-line examinations and methods for determining visual acuity will be conducted using the lowest line with the number of correctly identified optotypes ≥4/5 at 4 meters, or the lowest line with the number of optotypes ≥4/5 at 1 meter after conversion. This will be taken at the 1-,3-, 6-, and 12-month follow-up. An Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR E chart (Precision Vision, Villa Park, Illinois, USA) with standard illumination will measure distance visual acuity at a distance of 4 meters (a reflecting mirror will be used to achieve this testing distance if the space is limited). This visual acuity chart will be placed at a height such that the line of 20/20 is the same as the height of the participant's eyes.
- Undercorrected Visual Acuity at Month 1 [1 month]
Undercorrected Visual Acuity is characterized by line-by-line examinations and methods for determining visual acuity will be conducted using the lowest line with the number of correctly identified optotypes ≥4/5 at 4 meters, or the lowest line with the number of optotypes ≥4/5 at 1 meter after conversion. This will be taken at the 1-,3-, 6-, and 12-month follow-up. An Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR E chart (Precision Vision, Villa Park, Illinois, USA) with standard illumination will measure distance visual acuity at a distance of 4 meters (a reflecting mirror will be used to achieve this testing distance if the space is limited). This visual acuity chart will be placed at a height such that the line of 20/20 is the same as the height of the participant's eyes.
- Undercorrected Visual Acuity at Month 3 [3 months]
Undercorrected Visual Acuity is characterized by line-by-line examinations and methods for determining visual acuity will be conducted using the lowest line with the number of correctly identified optotypes ≥4/5 at 4 meters, or the lowest line with the number of optotypes ≥4/5 at 1 meter after conversion. This will be taken at the 1-,3-, 6-, and 12-month follow-up. An Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR E chart (Precision Vision, Villa Park, Illinois, USA) with standard illumination will measure distance visual acuity at a distance of 4 meters (a reflecting mirror will be used to achieve this testing distance if the space is limited). This visual acuity chart will be placed at a height such that the line of 20/20 is the same as the height of the participant's eyes.
- Undercorrected Visual Acuity Month 6 [6 months]
Undercorrected Visual Acuity is characterized by line-by-line examinations and methods for determining visual acuity will be conducted using the lowest line with the number of correctly identified optotypes ≥4/5 at 4 meters, or the lowest line with the number of optotypes ≥4/5 at 1 meter after conversion. This will be taken at the 1-,3-, 6-, and 12-month follow-up. An Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR E chart (Precision Vision, Villa Park, Illinois, USA) with standard illumination will measure distance visual acuity at a distance of 4 meters (a reflecting mirror will be used to achieve this testing distance if the space is limited). This visual acuity chart will be placed at a height such that the line of 20/20 is the same as the height of the participant's eyes.
- Undercorrected Visual Acuity at Year 1 [1 year]
Undercorrected Visual Acuity is characterized by line-by-line examinations and methods for determining visual acuity will be conducted using the lowest line with the number of correctly identified optotypes ≥4/5 at 4 meters, or the lowest line with the number of optotypes ≥4/5 at 1 meter after conversion. This will be taken at the 1-,3-, 6-, and 12-month follow-up. An Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR E chart (Precision Vision, Villa Park, Illinois, USA) with standard illumination will measure distance visual acuity at a distance of 4 meters (a reflecting mirror will be used to achieve this testing distance if the space is limited). This visual acuity chart will be placed at a height such that the line of 20/20 is the same as the height of the participant's eyes.
- Best Corrected Visual Acuity (BCVA) under non-cycloplegia and strabismus examination at Baseline [Baseline]
BCVA will be measured as results from autorefraction under non-cycloplegia will be performed for collection of all measurements. The best-corrected visual acuity of the child's left and right eyes will be recorded separately.
- Best Corrected Visual Acuity (BCVA) under non-cycloplegia and strabismus examination at Month 1 [1 month]
BCVA will be measured as results from autorefraction under non-cycloplegia will be performed for collection of all measurements. The best-corrected visual acuity of the child's left and right eyes will be recorded separately.
- Best Corrected Visual Acuity (BCVA) under non-cycloplegia and strabismus examination at Month 3 [3 months]
BCVA will be measured as results from autorefraction under non-cycloplegia will be performed for collection of all measurements. The best-corrected visual acuity of the child's left and right eyes will be recorded separately.
- Best Corrected Visual Acuity (BCVA) under non-cycloplegia and strabismus examination at Month 6 [6 months]
BCVA will be measured as results from autorefraction under non-cycloplegia will be performed for collection of all measurements. The best-corrected visual acuity of the child's left and right eyes will be recorded separately.
- Best Corrected Visual Acuity (BCVA) under non-cycloplegia and strabismus examination at Year 1 [1 year]
BCVA will be measured as results from autorefraction under non-cycloplegia will be performed for collection of all measurements. The best-corrected visual acuity of the child's left and right eyes will be recorded separately.
- Choroidal Thickness (ChT) at Baseline [Baseline]
ChT is measured as the perpendicular distance from the outer portion of the hyperreflective line corresponding to the retinal pigment epithelium to the posterior edge of the choroid as demarcated by the hyperreflective line corresponding to the chorioscleral interface using built-in automated layer segmentation software. This will be taken using the TOPCON Swept Source DRI OCT which is a non-contact, high-resolution tomographic and biomicroscopic imaging device for in-vivo viewing and measurement of posterior ocular structures.
- Choroidal Thickness (ChT) at Month 1 [1 month]
ChT is measured as the perpendicular distance from the outer portion of the hyperreflective line corresponding to the retinal pigment epithelium to the posterior edge of the choroid as demarcated by the hyperreflective line corresponding to the chorioscleral interface using built-in automated layer segmentation software. This will be taken using the TOPCON Swept Source DRI OCT which is a non-contact, high-resolution tomographic and biomicroscopic imaging device for in-vivo viewing and measurement of posterior ocular structures.
- Choroidal Thickness (ChT) at Months 3 [3 months]
ChT is measured as the perpendicular distance from the outer portion of the hyperreflective line corresponding to the retinal pigment epithelium to the posterior edge of the choroid as demarcated by the hyperreflective line corresponding to the chorioscleral interface using built-in automated layer segmentation software. This will be taken using the TOPCON Swept Source DRI OCT which is a non-contact, high-resolution tomographic and biomicroscopic imaging device for in-vivo viewing and measurement of posterior ocular structures.
- Choroidal Thickness (ChT) at Month 6 [6 months]
ChT is measured as the perpendicular distance from the outer portion of the hyperreflective line corresponding to the retinal pigment epithelium to the posterior edge of the choroid as demarcated by the hyperreflective line corresponding to the chorioscleral interface using built-in automated layer segmentation software. This will be taken using the TOPCON Swept Source DRI OCT which is a non-contact, high-resolution tomographic and biomicroscopic imaging device for in-vivo viewing and measurement of posterior ocular structures.
- Choroidal Thickness (ChT) at 1 Year [1 year]
ChT will be measured as the difference between each follow-up visit and baseline values.ChT is measured as the perpendicular distance from the outer portion of the hyperreflective line corresponding to the retinal pigment epithelium to the posterior edge of the choroid as demarcated by the hyperreflective line corresponding to the chorioscleral interface using built-in automated layer segmentation software. This will be taken using the TOPCON Swept Source DRI OCT which is a non-contact, high-resolution tomographic and biomicroscopic imaging device for in-vivo viewing and measurement of posterior ocular structures. ChT will be taken at 1-,3-, 6-, and 12-month follow-up visits.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of consent
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Age: ≥8 and ≤13 years at enrollment
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Myopia: Spherical equivalent refractions (SERs) under cycloplegia: -1.00 to -5.00 diopters (D)
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Astigmatism of 2.50 D or less
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Anisometropia of 1.50 D or less
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Corrected monocular logMAR visual acuity (VA): 1.0 or better
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Consent to participate in random allocation of grouping
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Fluent in English
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Willing and able to participate in all required activities of the study
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Race/ethnicity is either African, Hispanic, or Caucasian.
Exclusion Criteria:
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Strabismus and binocular vision abnormalities in either eye
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Ocular abnormalities in either eye or other systemic abnormalities that affect participate in all required activities of the study.
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Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.
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Other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrollment
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Noncompliance with treatment
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Children whose parents do not sign informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- University of California, San Francisco
- University of Melbourne
Investigators
- Principal Investigator: Julius Oatts, MD, University of California, San Francisco
Study Documents (Full-Text)
More Information
Publications
- 21-35793