High MyopiaNCT05768152
Repeated Low-Level Red-Light Therapy Shortens Axial Length
A study testing RLRL in people with High Myopia and Axial Length, run by The Second People's Hospital of Foshan at 1 site in China.
Trial summary
The purpose of this clinical trial is to investigate the incidence and magnitude of axial length shortening after repeated low-level red-light therapy in high myopia children and teenagers. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- High Myopia, Axial Length, Eye Diseases
- What is being tested?
- RLRL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Provision of consent.
- Age: ≥ 8 and ≤ 18 years at enrolment.
- High myopia: cycloplegic sphere of -6.00 diopters (D) or greater in both eyes.
- Willing and able to participate in all required activities of the study.
- The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
- Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.
Who cannot join
- Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
- Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
- Strabismus and binocular vision abnormalities in either eye.
- Previous any intraocular surgery affecting refractive status.
- Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Trial locations and contacts
1 site in 1 country.
Yanping Chen, MD contact
China1 site
The Second People's Hospital of Foshan
Foshan, Guangdong, 528000
Xiangbin Kong, MD, PhD, +8613929994766, xiangbin_kong@sina.com
About this study
Official title: Repeated Low-level Red-light Therapy in High Myopia Children and Teenagers: a Prospective Single-arm Study
The purpose of this clinical trial is to investigate the incidence and magnitude of axial length shortening after repeated low-level red-light therapy in high myopia children and teenagers.
Read the detailed description
High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. Repeated low-level red-light (RLRL) therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.
The purpose of this study is to investigate and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in highly myopic children and teenagers aged 8-18 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents/guardians according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, slit lamp, fundus camera and optical coherence tomography/angiography will be measured at 1-, 3-, 6- and 12-month follow-up visits.
- Conditions
- High Myopia, Axial Length, Eye Diseases
- Being tested
- RLRL
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLRLDevice
RLRL will be performed twice per day with an interval of at least 4 hours, each treatment last 3 minutes, in addition to single vision spectacles with power for correcting distance refraction.
| Study group | Role | What they receive |
|---|---|---|
| Repeated low-level red-light (RLRL) therapy | Experimental | single vision spectacles \& RLRL Receives: Device: RLRL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of axial length shortening greater than 0.05 mm
Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.05 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.
Measured: 12 months
Secondary outcomes (11)
Incidence rates of axial length reduction greater than 0.10 mm and 0.20 mm
Incidence rates of axial length shortening > 0.10 mm and 0.20 mm are characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.10 mm and 0.20 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.
Measured: 12 months
Magnitude of axial length shortening among shortened eyes
The magnitude of axial length shortening is characterized as the amount of axial length reduction in eyes with axial shortening. Axial length (mm) is measured using the IOL Master.
Measured: 12 months
Changes in choroidal thickness (μm)
Changes in choroidal thickness are characterized as the difference between each follow-up visit and corresponding baseline values which are measured using the optical coherence tomography.
Measured: 1, 3, 6 and 12 months
Changes in axial length (mm)
Changes of axial length is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Measured: 1, 3, 6 and 12 months
Changes in corneal curvature (mm)
Changes of corneal curvature is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Measured: 1, 3, 6 and 12 months
Changes in anterior chamber depth (mm)
Changes of anterior chamber depth is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Measured: 1, 3, 6 and 12 months
Changes in white to white (mm)
Changes of white to white is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Measured: 1, 3, 6 and 12 months
Change of cycloplegic spherical equivalent refraction
Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Refraction with full cycloplegia is performed with an autorefractor. The data on spherical and cylindrical power and axis is automatically extracted from the autorefractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D).
Measured: 1, 3, 6 and 12 months
Change of pathologic myopia fundus META-PM grading
The fundus images are classified based on META-PM classification system. Color fundus images are obtained using the fundus camera.
Measured: 1, 3, 6 and 12 months
Change in best corrected visual acuity
Best corrected visual acuity change is characterized as the difference between each follow-up visit and baseline values. Visual acuity is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart with standard illumination at a distance of 4 meters.
Measured: 1, 3, 6 and 12 months
Incidence of self-reported adverse events
Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.
Measured: 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second People's Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768152
- Sponsor's protocol ID
- (2022)-0131
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared as open data after proper anonymization.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Low-level Red-light Therapy in High Myopia Children and Teenagers: a Prospective Single-arm Study
- ClinicalTrials.gov ID
- NCT05768152
- Acronym / sponsor ID
- (2022)-0131
- Conditions
- High Myopia, Axial Length, Eye Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Second People's Hospital of FoshanUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to investigate the incidence and magnitude of axial length shortening after repeated low-level red-light therapy in high myopia children and teenagers.
Detailed description
High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. Repeated low-level red-light (RLRL) therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.
The purpose of this study is to investigate and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in highly myopic children and teenagers aged 8-18 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents/guardians according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, slit lamp, fundus camera and optical coherence tomography/angiography will be measured at 1-, 3-, 6- and 12-month follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repeated low-level red-light (RLRL) therapy | Experimental | Device: RLRLsingle vision spectacles \& RLRL |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Provision of consent.
- Age: ≥ 8 and ≤ 18 years at enrolment.
- High myopia: cycloplegic sphere of -6.00 diopters (D) or greater in both eyes.
- Willing and able to participate in all required activities of the study.
- The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
Key exclusion criteria (5 listed)
- Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
- Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
- Strabismus and binocular vision abnormalities in either eye.
- Previous any intraocular surgery affecting refractive status.
- Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RLRLRLRL will be performed twice per day with an interval of at least 4 hours, each treatment last 3 minutes, in addition to single vision spectacles with power for correcting distance refraction. | Device | Repeated low-level red-light (RLRL) therapy |
Primary outcome
Incidence rate of axial length shortening greater than 0.05 mm
Time frame: 12 months
Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.05 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.
11 secondary outcomes
Incidence rates of axial length reduction greater than 0.10 mm and 0.20 mm
Time frame: 12 months
Magnitude of axial length shortening among shortened eyes
Time frame: 12 months
Changes in choroidal thickness (μm)
Time frame: 1, 3, 6 and 12 months
Changes in axial length (mm)
Time frame: 1, 3, 6 and 12 months
Changes in corneal curvature (mm)
Time frame: 1, 3, 6 and 12 months
Changes in anterior chamber depth (mm)
Time frame: 1, 3, 6 and 12 months
Changes in white to white (mm)
Time frame: 1, 3, 6 and 12 months
Change of cycloplegic spherical equivalent refraction
Time frame: 1, 3, 6 and 12 months
Change of pathologic myopia fundus META-PM grading
Time frame: 1, 3, 6 and 12 months
Change in best corrected visual acuity
Time frame: 1, 3, 6 and 12 months
Incidence of self-reported adverse events
Time frame: 1, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: Yes. Data will be shared as open data after proper anonymization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanping Chen, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RLRL in people with High Myopia and Axial Length, run by The Second People's Hospital of Foshan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangbin Kong, MD, PhD (+8613929994766, xiangbin_kong@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of axial length shortening greater than 0.05 mm (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.