MyopiaNCT05597397
Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure
A study testing RLRL in people with Myopia and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the effect of repeated low-level red-light (RLRL) therapy on the retinal function and structure among myopic teenagers. Read more about this study
- Who is it for?
- Ages 15 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Refractive Errors, 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
- 41 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 15 Jun 2023
- 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 15 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 15-16 years at enrolment.
- Myopia: cycloplegic spherical equivalent refractions (SERs) range from -1.00 to -5.00 diopters (D) and astigmatism less than -2.5 D in either eye.
- Best corrected visual acuity equal to or better than 0.8 in either eye.
- Normal fundus, or tessellated fundus.
- Provision of consent and able to participate in all required activities of the study.
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.
- Strabismus and binocular vision abnormalities in either eye.
- Refractive media opacity: corneal opacities, cataract, or implanted intraocular lens, etc.
- Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
- Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
- Systemic abnormalities: diabetes, hypertension, etc.
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- Drugs therapies with toxicity effect on the retina: hydroxychloroquine, etc.
- Prior treatment of myopia control in the past three months, drugs, orthokeratology, progressive addition lenses, bifocal lens, etc.
- Other contraindications, 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.
China1 site
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 20041
About this study
Official title: Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure Among Myopic Teenagers
The purpose of this clinical trial is to evaluate the effect of repeated low-level red-light (RLRL) therapy on the retinal function and structure among myopic teenagers.
Read the detailed description
Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration has been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life. Repeated low-level red-light (RLRL) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. A previous randomized clinical trial suggested that RLRL could effectively controlled myopia progression without clinically observable side effects.
The purpose of this study is to evaluate the effect of RLRL on the retinal function and structure among myopic teenagers aged 15-16 years. The RLRL therapy will be carried out at school under supervision of the parents according to a standard protocol for the first month and then will be discontinued for 1 month. Detailed functional and structural examinations, including full field electroretinogram, multifocal electroretinogram, microperimetry, visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, cycloplegic spherical equivalent refraction, and biological parameters will be evaluated at 1 month, 2 months after enrollment.
- Conditions
- Myopia, Refractive Errors, Eye Diseases, Retina; Change
- Being tested
- RLRL
- Medical subject headings
- Myopia, Refractive Errors, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLRLDevice
In addition to SVS with power for correcting distance refraction, RLRL will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Repeated Low-Level Red-Light Therapy (RLRL) | Experimental | Single vision spectacles (SVS) \& RLRL. Receives: Device: RLRL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the amplitudes of waves.
Changes in the amplitudes are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
Measured: 1 and 2 months
Changes in the latency of waves.
Changes in the latency of waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
Measured: 1 and 2 months
Secondary outcomes (8)
Changes in retinal sensitivity
Changes in retinal sensitivity are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by microperimetry.
Measured: 1 and 2 months
Changes in fixation stability
Changes in fixation stability are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by microperimetry.
Measured: 1 and 2 months
Changes in macular integrity
Changes in macular integrity are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by microperimetry.
Measured: 1 and 2 months
Changes in macular vessel density
Changes in macular vessel density are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography angiography.
Measured: 1 and 2 months
Changes in macular perfusion density
Changes in macular perfusion density are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography angiography.
Measured: 1 and 2 months
Changes in chorocapillaris flow defict percentage
Changes in choroidal vascularity index are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography angiography.
Measured: 1 and 2 months
Changes in choroidal vascularity index
Changes in choroidal vascularity index are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography.
Measured: 1 and 2 months
Changes in best corrected visual acuity
Best corrected visual acuity changes are characterized as the difference between each follow up visit and baseline values. An Early Treatment Diabetic Retinopathy Study chart with standard illumination at a distance of 4 meters is used to measure best corrected visual acuity.
Measured: 1 and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Mar 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597397
- Sponsor's protocol ID
- RLS-SEPTC-2022
- Status last verified
- Nov 2024
- First submitted
- 20 Sep 2022
- Last updated
- 5 Nov 2024
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure Among Myopic Teenagers
- ClinicalTrials.gov ID
- NCT05597397
- Acronym / sponsor ID
- RLS-SEPTC-2022
- Conditions
- Myopia, Refractive Errors, Eye Diseases, Retina; Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 28 Oct 2022 (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 evaluate the effect of repeated low-level red-light (RLRL) therapy on the retinal function and structure among myopic teenagers.
Detailed description
Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration has been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life. Repeated low-level red-light (RLRL) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. A previous randomized clinical trial suggested that RLRL could effectively controlled myopia progression without clinically observable side effects.
The purpose of this study is to evaluate the effect of RLRL on the retinal function and structure among myopic teenagers aged 15-16 years. The RLRL therapy will be carried out at school under supervision of the parents according to a standard protocol for the first month and then will be discontinued for 1 month. Detailed functional and structural examinations, including full field electroretinogram, multifocal electroretinogram, microperimetry, visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, cycloplegic spherical equivalent refraction, and biological parameters will be evaluated at 1 month, 2 months after enrollment.
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 Therapy (RLRL) | Experimental | Device: RLRLSingle vision spectacles (SVS) \& RLRL. |
Who may qualify
- Ages
- 15 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: 15-16 years at enrolment.
- Myopia: cycloplegic spherical equivalent refractions (SERs) range from -1.00 to -5.00 diopters (D) and astigmatism less than -2.5 D in either eye.
- Best corrected visual acuity equal to or better than 0.8 in either eye.
- Normal fundus, or tessellated fundus.
- Provision of consent and able to participate in all required activities of the study.
Key exclusion criteria (9 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.
- Strabismus and binocular vision abnormalities in either eye.
- Refractive media opacity: corneal opacities, cataract, or implanted intraocular lens, etc.
- Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
- Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
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 |
|---|---|---|
| RLRLIn addition to SVS with power for correcting distance refraction, RLRL will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes. | Device | Repeated Low-Level Red-Light Therapy (RLRL) |
Primary outcome
Changes in the amplitudes of waves.
Time frame: 1 and 2 months
Changes in the amplitudes are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
Changes in the latency of waves.
Time frame: 1 and 2 months
Changes in the latency of waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
8 secondary outcomes
Changes in retinal sensitivity
Time frame: 1 and 2 months
Changes in fixation stability
Time frame: 1 and 2 months
Changes in macular integrity
Time frame: 1 and 2 months
Changes in macular vessel density
Time frame: 1 and 2 months
Changes in macular perfusion density
Time frame: 1 and 2 months
Changes in chorocapillaris flow defict percentage
Time frame: 1 and 2 months
Changes in choroidal vascularity index
Time frame: 1 and 2 months
Changes in best corrected visual acuity
Time frame: 1 and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myopia and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 5 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the amplitudes of waves. (time frame: 1 and 2 months). The study lists 2 primary outcomes in all. 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 5 Nov 2024.