- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05871840
Effectiveness and Safety of Repeated Low-Level Red-Light Therapy on Myopia Control Among Children and Adolescents
Real-World Evidence: Effectiveness and Safety of Repeated Low-Level Red-Light Therapy on Myopia Control Among Children and Adolescents
Myopia has become one of the leading causes of visual impairment globally and brings a heavy burden on the society. Therefore, preventing and controlling the progression of myopia has become an urgent public health issue that needs to be addressed.
The purpose of this study is to provide real-world evidence for identifying the incidence of myopia control (axial length growth rate ≤ 0.1mm/year) after 36-month RLRL therapy, and long-term safety of RLRL therapy in children and adolescents.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The prevalence of myopia in children is increasing worldwide and is viewed as a major public health concern. The current methods for myopia control include medication (e.g., atropine eye drops), optical (e.g., orthokeratology) and environmental interventions (e.g., time outdoors). Nevertheless, these treatments still have limitations. For example, low-concentration atropine may cause systemic side effects and accommodation loss caused by ciliary muscle paralysis. Moreover, the use of orthokeratology in children poses problems such as difficulty wearing, low compliance, and possible complications such as severe corneal infections. Thus, developing the more effective and safe treatment for myopia control in children and adolescents is the future research direction.
Recently, repeated low-level red-light (RLRL) therapy has emerged as a treatment for myopia control in children and adolescents, with promising efficacy and safety. It is suggested that continued RLRL therapy sustained promising efficacy and safety in slowing myopia progression within 2 years. However, relevant information on the effectiveness and safety of RLRL therapy on myopia control over 2 years among children and adolescents remain scarce, which deserves to be further explored.
In this multicenter observational study, the investigators aim to recruit 360 children aged 7-18 years who have currently accepted RLRL therapy at 3 study centers in China. All participants are randomly selected by stratified sampling based on the treatment duration of RLRL therapy (6-12 months, 12-24 months, 24-36 months, 36 months or more). First, the investigators will confirm whether these participants have pre-treatment data (before starting RLRL therapy), including visual acuity, axial length and cycloplegic refraction. Then all the eligible participants who meet the preliminary inclusion criteria, will be invited to come to the corresponding hospitals and further undergo the comprehensive ophthalmic examinations, including visual acuity, measurement of ocular biometric parameters, cycloplegic refraction, slit-lamp examination, color fundus photography, optical coherence tomography (OCT), electroretinography (ERG) and questionnaire surveys.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xiong Jiping
- Phone Number: 18126081918
- Email: 377721053@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 7-18 years old
- Myopia of cycloplegic spherical equivalent refraction (SER) of -1.0D or greater in both of eyes before starting RLRL therapy
- Participants undergo RLRL therapy currently
- With complete examination data before starting RLRL therapy, including visual acuity, axial length and cycloplegic spherical equivalence refraction
- The subject and their guardian voluntarily sign the informed consent form
Exclusion Criteria:
- Presence of strabismus, binocular vision abnormalities, other ocular abnormalities in either eye
- Secondary myopia (such as myopia caused by retinopathy of prematurity or other eye diseases in infancy or early childhood) or myopia associated with systemic syndromes (such as Marfan syndrome)
- Presence of other significant ocular and/or systemic diseases or abnormalities
- Medical history of previous eye surgery, laser treatment, or intravitreal injection and so on
- Participants if investigators believe they have contraindications that make them unsuitable for participation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Treatment duration of RLRL therapy (≥ 6 months and < 12 months)
|
This treatment device was made by Eyerising SuzhouXuanjia Optoelectronics Technology, which has been on the market and used widely for amblyopia treatment for the past decade in China.
This device is certified as a class IIa device by the China National Medical Products Administration.
It consists of semiconductor laser diodes, which deliver low-level red light with a wavelength of 650 ±10 nm at an illuminance level of approximately 1600 lux through the pupil to the fundus.
Based on calculations completed by an independent lab, the light power going through a 4-mm pupil is 0.29 mW and is classified as class 1 under the International Electrotechnical Commission 60825-1:2014 standard, which is at a level considered safe for direct ocular exposure that would not create retinal thermal hazard.
|
Treatment duration of RLRL therapy (≥12 months and < 24 months)
|
This treatment device was made by Eyerising SuzhouXuanjia Optoelectronics Technology, which has been on the market and used widely for amblyopia treatment for the past decade in China.
This device is certified as a class IIa device by the China National Medical Products Administration.
It consists of semiconductor laser diodes, which deliver low-level red light with a wavelength of 650 ±10 nm at an illuminance level of approximately 1600 lux through the pupil to the fundus.
Based on calculations completed by an independent lab, the light power going through a 4-mm pupil is 0.29 mW and is classified as class 1 under the International Electrotechnical Commission 60825-1:2014 standard, which is at a level considered safe for direct ocular exposure that would not create retinal thermal hazard.
|
Treatment duration of RLRL therapy (≥24 months and < 36 months)
|
This treatment device was made by Eyerising SuzhouXuanjia Optoelectronics Technology, which has been on the market and used widely for amblyopia treatment for the past decade in China.
This device is certified as a class IIa device by the China National Medical Products Administration.
It consists of semiconductor laser diodes, which deliver low-level red light with a wavelength of 650 ±10 nm at an illuminance level of approximately 1600 lux through the pupil to the fundus.
Based on calculations completed by an independent lab, the light power going through a 4-mm pupil is 0.29 mW and is classified as class 1 under the International Electrotechnical Commission 60825-1:2014 standard, which is at a level considered safe for direct ocular exposure that would not create retinal thermal hazard.
|
Treatment duration of RLRL therapy (≥36 months)
|
This treatment device was made by Eyerising SuzhouXuanjia Optoelectronics Technology, which has been on the market and used widely for amblyopia treatment for the past decade in China.
This device is certified as a class IIa device by the China National Medical Products Administration.
It consists of semiconductor laser diodes, which deliver low-level red light with a wavelength of 650 ±10 nm at an illuminance level of approximately 1600 lux through the pupil to the fundus.
Based on calculations completed by an independent lab, the light power going through a 4-mm pupil is 0.29 mW and is classified as class 1 under the International Electrotechnical Commission 60825-1:2014 standard, which is at a level considered safe for direct ocular exposure that would not create retinal thermal hazard.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of myopia control after 36-month RLRL therapy
Time Frame: 36 months or more
|
Validity index: myopia control was defined as axial length growth rate ≤ 0.1mm/year
|
36 months or more
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incident visual impairment (logMAR visual acuity < 0.8)
Time Frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Safety index
|
6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Incident structural damage of the retina and choroid
Time Frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Safety index
|
6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Change of axial length per year after RLRL therapy.
Time Frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Validity index
|
6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Change of spherical equivalent refraction per year after RLRL therapy
Time Frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Validity index
|
6-12 months, 12-24 months, 24-36 months, 36 months or more
|
The incidence of myopia control after 6-,12- and 24-month RLRL therapy
Time Frame: 6-12 months, 12-24 months, 24-36 months
|
Validity index: myopia control was defined as axial length growth rate ≤ 0.1mm/year
|
6-12 months, 12-24 months, 24-36 months
|
Incident adverse event
Time Frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Safety index: adverse events including but not limited to dazzling, short-term glare, flash blindness, and delayed afterimages
|
6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Incident severe adverse event
Time Frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Safety index: including but not limited to sudden visual loss of >2 lines occurring or a scotoma perceived to develop in the center of the visual field.
|
6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Abnormality of the retinal function
Time Frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Safety index: retinal function is evaluated by electroretinogram (ERG)
|
6-12 months, 12-24 months, 24-36 months, 36 months or more
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fang Yu, Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LL-KT-2023006-X1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myopia
-
He Eye HospitalNot yet recruiting
-
University of BradfordCoopervision, Inc.; University of HuddersfieldNot yet recruiting
-
Visioneering Technologies, IncRecruitingMyopiaUnited States, Canada, Hong Kong, Singapore
-
University Eye Hospital, FreiburgRecruiting
-
Shanghai 10th People's HospitalCompletedMyopia | Myopia, ProgressiveChina
-
Tianjin Eye HospitalActive, not recruiting
-
Tianjin Eye HospitalCompleted
-
Sultan Qaboos UniversityChristian Medical College, Vellore, IndiaUnknown
-
Peking University People's HospitalUnknownProgressive MyopiaChina
-
Shanghai Eye Disease Prevention and Treatment CenterNot yet recruiting
Clinical Trials on Repeated Low-Level Red-Light (RLRL) Therapy
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe Second People's Hospital of Foshan; Tianjin Medical University Eye CenterRecruitingEye Diseases | Refractive Errors | Myopia, ProgressiveChina
-
Beijing Airdoc Technology Co., Ltd.Ningbo Eye HospitalActive, not recruiting
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruitingEffect of Repeated Low-Level Red-Light Therapy on Visual Field Damage in Primary Open-angle GlaucomaEye Diseases | Open Angle GlaucomaChina
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityXiangya Hospital of Central South University; Shenzhen Children's Hospital; The...Active, not recruitingEye Diseases | Refractive Errors | MyopiaChina
-
University of British ColumbiaUnknownVitiligo | Melasma | Lichen Planus PigmentosusCanada
-
University of California, San FranciscoUniversity of MelbourneRecruiting
-
Beijing Airdoc Technology Co., Ltd.RecruitingMyopia | AmblyopiaChina
-
University of HoustonUniversity of LouisvilleCompletedDry Eye | Meibomian Gland DysfunctionUnited States
-
Beijing Airdoc Technology Co., Ltd.Shanghai Children's Medical CenterRecruiting
-
University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloCompleted