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
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.