MyopiaNCT06738095
Effect of Low-level Red-light on Ultra-high Myopia
A study testing daily low-level red-light in people with Myopia, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
100 eyes of ultra-high myopia were treated with daily low-level red-light. The age of children ranged from 3 to 16.3 years. The follow-up duration was one year. The objective was to explore the effect of daily low-level red-light on ultra-high myopia treatment Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Myopia
- What is being tested?
- daily low-level red-light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2022to 23 Aug 2022
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The age is over 3 years old and under 18 years old. B. The spherical equivalent error is ≤ -6 D diopter . D. be able to cooperate to complete various eye examinations. E. be able to attend follow-up according to the specified time. F the guardian can accompany the use of the instrument.
Who cannot join
- Complications associated with high myopia (such as choroidal neovascularization, macular split or hole, Rhegmatogenous retinal detachment); B other macular diseases (central serous retinopathy) or other eye diseases (e.g.Glaucoma, cataract, uveitis); C complicated with photosensitivity, psoriasis, albinism, hyperactivity disorder, nephrotic syndrome and systemic erythema Immune system diseases such as lupus; D. other systemic diseases or pregnancy; E. other similar instruments have been used for treatment in the past six months.
- can't cooperate to complete various eye examinations. G. The guardian cannot accompany the use of this instrument.
Trial locations and contacts
1 site in 1 country.
About this study
100 eyes of ultra-high myopia were treated with daily low-level red-light. The age of children ranged from 3 to 16.3 years. The follow-up duration was one year. The objective was to explore the effect of daily low-level red-light on ultra-high myopia treatment
- Conditions
- Myopia
- Being tested
- daily low-level red-light
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily low-level red-lightDevice
Daily low-level red-light is a kind of myopia intervention. Red-light typically using 650-nm wave of length. The treatment duration last 3 minutes each time, every day children were anticipated to use two times, at home.
| Study group | Role | What they receive |
|---|---|---|
| red-light | Experimental | Children with ultra-high myopia were treated with daily low-level red-light, which was used twice a day, with four hours interval. Three minutes for each session of treatment Receives: Device: daily low-level red-light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in axial length
One year changes in axial length
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start18 Jan 2022
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
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.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, cao kai, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738095
- Sponsor's protocol ID
- BeijingTH TRECKY239
- Status last verified
- Jan 2022
- First submitted
- 13 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Red-light on Ultra-high Myopia
- ClinicalTrials.gov ID
- NCT06738095
- Acronym / sponsor ID
- BeijingTH TRECKY239
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 17 Dec 2024 (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.
100 eyes of ultra-high myopia were treated with daily low-level red-light. The age of children ranged from 3 to 16.3 years. The follow-up duration was one year. The objective was to explore the effect of daily low-level red-light on ultra-high myopia treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| red-light | Experimental | Device: daily low-level red-lightChildren with ultra-high myopia were treated with daily low-level red-light, which was used twice a day, with four hours interval. Three minutes for each session of treatment |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The age is over 3 years old and under 18 years old. B. The spherical equivalent error is ≤ -6 D diopter . D. be able to cooperate to complete various eye examinations. E. be able to attend follow-up according to the specified time. F the guardian can accompany the use of the instrument.
Key exclusion criteria (2 listed)
- Complications associated with high myopia (such as choroidal neovascularization, macular split or hole, Rhegmatogenous retinal detachment); B other macular diseases (central serous retinopathy) or other eye diseases (e.g.Glaucoma, cataract, uveitis); C complicated with photosensitivity, psoriasis, albinism, hyperactivity disorder, nephrotic syndrome and systemic erythema Immune system diseases such as lupus; D. other systemic diseases or pregnancy; E. other similar instruments have been used for treatment in the past six months.
- can't cooperate to complete various eye examinations. G. The guardian cannot accompany the use of this instrument.
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 |
|---|---|---|
| daily low-level red-lightDaily low-level red-light is a kind of myopia intervention. Red-light typically using 650-nm wave of length. The treatment duration last 3 minutes each time, every day children were anticipated to use two times, at home. | Device | red-light |
Primary outcome
Changes in axial length
Time frame: one year
One year changes in axial length
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 17 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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 daily low-level red-light in people with Myopia, run by Beijing Tongren Hospital 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 1 inclusion and 2 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 17 Dec 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 axial length (time frame: one year). 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 17 Dec 2024.