MyopiaNCT07330180
Multicenter RCT: LED Red Light Dose-Response in Myopia Progression Control
A study testing Yingtong Vision Rehabilitation Instrument and Hoya DIMS multi-point myopia defocus lens in people with Myopia and Myopia, Progressive, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 7 sites in China.
Trial summary
The goal of this clinical trial is to verify the effectiveness and safety of non-laser LED red light combined with defocus lens therapy for controlling myopia progression and evaluate the impact of different intervention durations in 6-14 years old children and adolescents with myopia (spherical equivalent refraction… Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopia, Progressive
- What is being tested?
- Yingtong Vision Rehabilitation Instrument and Hoya DIMS multi-point myopia defocus lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 7 sitesChina
- Study dates
- 1 Jan 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 6 to 14 years old, regardless of gender;
- After cycloplegic autorefraction, monocular or binocular spherical equivalent refraction (SER) meets: -6.00D ≤ SER ≤ -1.00D, and binocular best-corrected visual acuity (BCVA) ≥ 0.8 (logMAR 0.1; Snellen 20/25);
- Binocular anisometropia ≤ 1.50D; astigmatism ≤ 2.50D;
- Able to understand the purpose of the study, willing to participate in this clinical verification, sign the informed consent form personally or through their legal guardian, and cooperate with the entire trial process (12 months).
Who cannot join
- Photophobia or allergy to cycloplegic agents (e.g., tropicamide or cyclopentolate);
- Received any of the following myopia control measures within one month (including but not limited to): low-concentration atropine eye drops, orthokeratology lenses, myopia control-related frame glasses, low-level red light therapy, defocus soft contact lenses, or defocus RGP lenses;
- Subjects with ocular diseases that may affect visual acuity or refractive error (e.g., lens disorders such as cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, etc.);
- Neurological diseases (previous convulsion history, epilepsy, tic disorders, central nervous system developmental abnormalities) or mental and psychological diseases;
- Systemic diseases: immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function impairment, severe liver and kidney dysfunction, acute or chronic sinusitis, or diabetes mellitus;
- Binocular manifest strabismus or any other pathological changes of the eyeball or acute inflammatory ocular diseases;
- Subjects deemed inappropriate by the investigator.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 401122
The Second People's Hospital of Foshan City
Foshan, Guangdong, 528000
The First Affiliated Hospital of Guangxi Medical University
Guilin, Nanning, 530021
The Fourth People's Hospital of Shenyang City
Shenyang, Liaoning, 110032
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710001
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Multicenter, Open-Label, Parallel-Group, Randomized Controlled Study Comparing the Dose-Response Relationship of LED Red Light in Controlling Myopia Progression
The goal of this clinical trial is to verify the effectiveness and safety of non-laser LED red light combined with defocus lens therapy for controlling myopia progression and evaluate the impact of different intervention durations in 6-14 years old children and adolescents with myopia (spherical equivalent refraction: -6.00D ≤ SER ≤ -1.00D), regardless of gender. The main questions it aims to answer are:
[primary hypothesis or outcome measure 1]: Does the combination of Yingtong Vision Rehabilitation Instrument (non-laser LED red light) and Hoya DIMS defocus lens show non-inferior effectiveness to Hoya DIMS defocus lens alone in controlling 6-month axial length change? [primary hypothesis or outcome measure 2]: Do different single intervention durations (2min, 3min, 4min) of non-laser LED red light affect the effectiveness (e.g., axial length change at multiple time points, 12-month SER change) and safety of the combined therapy? If there is a comparison group: Researchers will compare Test Group A (2min PBM therapy + DIMS lenses), Test Group B (3min PBM therapy + DIMS lenses), Test Group C (4min PBM therapy + DIMS lenses), and Control Group D (DIMS lenses alone)] to see if the combined therapy has similar or better myopia control effects and comparable safety, and to identify the optimal intervention duration.
Read more
Participants will:
Complete screening examinations (axial length, refractive error, visual acuity, IOP, fundus photography, OCT, etc.) and sign the informed consent form.
Be randomly assigned to one of the four groups and receive the corresponding intervention (use the Yingtong Vision Rehabilitation Instrument as per group-specific duration twice a day, with ≥4-hour interval, plus DIMS lenses; or only DIMS lenses).
Attend regular follow-up visits at 30 days, 3 months, 6 months, 9 months, and 12 months for efficacy and safety assessments (including repeated ocular examinations and adverse event reporting).
Cooperate with the entire 12-month trial process and comply with the device usage specifications and follow-up requirements.
- Conditions
- Myopia, Myopia, Progressive
- Being tested
- Yingtong Vision Rehabilitation Instrument, Hoya DIMS multi-point myopia defocus lens
- Keywords
- Myopia, Children, Axial Length, Red-light Therapy
- Medical subject headings
- Myopia, Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yingtong Vision Rehabilitation InstrumentDevice
Input voltage: 6V (4 × 1.5V alkaline dry batteries). Red light wavelength: 650nm; light spot diameter: outer diameter 5.0mm, inner diameter 1.5mm.
Light source output power: 1.6 mW (±0.1mW at 30mm from the observation window). The Yingtong Vision Rehabilitation Instrument should be used twice a day under the regular communication and supervision of hospital optometrists/coordinators (via phone, WeChat, etc.), with an interval of at least 4 hours.
Hoya DIMS multi-point myopia defocus lensDevice
Frame glasses worn on the bridge of the nose
| Study group | Role | What they receive |
|---|---|---|
| Test Group A | Experimental | PBM therapy with single intervention duration of 2 minutes + wearing Hoya DIMS defocus lens Receives: Device: Yingtong Vision Rehabilitation Instrument; Device: Hoya DIMS multi-point myopia defocus lens |
| Test Group B | Experimental | PBM therapy with single intervention duration of 3 minutes + wearing Hoya DIMS defocus lens Receives: Device: Yingtong Vision Rehabilitation Instrument; Device: Hoya DIMS multi-point myopia defocus lens |
| Test Group C | Experimental | PBM therapy with single intervention duration of 4 minutes + wearing Hoya DIMS defocus lens Receives: Device: Yingtong Vision Rehabilitation Instrument; Device: Hoya DIMS multi-point myopia defocus lens |
| Control Group D | Active comparator | Wearing Hoya DIMS defocus lens only Receives: Device: Hoya DIMS multi-point myopia defocus lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month axial length change
The difference in axial length at 6 months after trial initiation compared with the baseline axial length
Measured: 6-month
Secondary outcomes (2)
1-, 3-, 9- and 12-month axial length changes
The difference in axial length at 1-, 3-, 9- and 12-month after trial initiation compared with the baseline axial length
Measured: 1-, 3-, 9- and 12-month
12-month spherical equivalent refraction (SER) change
The difference in spherical equivalent refraction at 12-month after trial initiation compared with the baseline spherical equivalent refraction
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojuan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330180
- Sponsor's protocol ID
- 20251009041118960
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.
PubMed 14985292Zhao J, Pan X, Sui R, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from Shunyi District, China. Am J Ophthalmol. 2000 Apr;129(4):427-35. doi: 10.1016/s0002-9394(99)00452-3.
PubMed 10764849Maul E, Barroso S, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from La Florida, Chile. Am J Ophthalmol. 2000 Apr;129(4):445-54. doi: 10.1016/s0002-9394(99)00454-7.
PubMed 10764851Pokharel GP, Negrel AD, Munoz SR, Ellwein LB. Refractive Error Study in Children: results from Mechi Zone, Nepal. Am J Ophthalmol. 2000 Apr;129(4):436-44. doi: 10.1016/s0002-9394(99)00453-5.
PubMed 10764850Mutti DO, Hayes JR, Mitchell GL, Jones LA, Moeschberger ML, Cotter SA, Kleinstein RN, Manny RE, Twelker JD, Zadnik K; CLEERE Study Group. Refractive error, axial length, and relative peripheral refractive error before and after the onset of myopia. Invest Ophthalmol Vis Sci. 2007 Jun;48(6):2510-9. doi: 10.1167/iovs.06-0562.
PubMed 17525178Zadnik K, Sinnott LT, Cotter SA, Jones-Jordan LA, Kleinstein RN, Manny RE, Twelker JD, Mutti DO; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study Group. Prediction of Juvenile-Onset Myopia. JAMA Ophthalmol. 2015 Jun;133(6):683-9. doi: 10.1001/jamaophthalmol.2015.0471.
PubMed 25837970Zhang M, Gazzard G, Fu Z, Li L, Chen B, Saw SM, Congdon N. Validating the accuracy of a model to predict the onset of myopia in children. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5836-41. doi: 10.1167/iovs.10-5592.
PubMed 21330664Jones-Jordan LA, Sinnott LT, Manny RE, Cotter SA, Kleinstein RN, Mutti DO, Twelker JD, Zadnik K; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study Group. Early childhood refractive error and parental history of myopia as predictors of myopia. Invest Ophthalmol Vis Sci. 2010 Jan;51(1):115-21. doi: 10.1167/iovs.08-3210. Epub 2009 Sep 8.
PubMed 19737876Tedja MS, Wojciechowski R, Hysi PG, Eriksson N, Furlotte NA, Verhoeven VJM, Iglesias AI, Meester-Smoor MA, Tompson SW, Fan Q, Khawaja AP, Cheng CY, Hohn R, Yamashiro K, Wenocur A, Grazal C, Haller T, Metspalu A, Wedenoja J, Jonas JB, Wang YX, Xie J, Mitchell P, Foster PJ, Klein BEK, Klein R, Paterson AD, Hosseini SM, Shah RL, Williams C, Teo YY, Tham YC, Gupta P, Zhao W, Shi Y, Saw WY, Tai ES, Sim XL, Huffman JE, Polasek O, Hayward C, Bencic G, Rudan I, Wilson JF; CREAM Consortium; 23andMe Research Team; UK Biobank Eye and Vision Consortium; Joshi PK, Tsujikawa A, Matsuda F, Whisenhunt KN, Zeller T, van der Spek PJ, Haak R, Meijers-Heijboer H, van Leeuwen EM, Iyengar SK, Lass JH, Hofman A, Rivadeneira F, Uitterlinden AG, Vingerling JR, Lehtimaki T, Raitakari OT, Biino G, Concas MP, Schwantes-An TH, Igo RP Jr, Cuellar-Partida G, Martin NG, Craig JE, Gharahkhani P, Williams KM, Nag A, Rahi JS, Cumberland PM, Delcourt C, Bellenguez C, Ried JS, Bergen AA, Meitinger T, Gieger C, Wong TY, Hewitt AW, Mackey DA, Simpson CL, Pfeiffer N, Parssinen O, Baird PN, Vitart V, Amin N, van Duijn CM, Bailey-Wilson JE, Young TL, Saw SM, Stambolian D, MacGregor S, Guggenheim JA, Tung JY, Hammond CJ, Klaver CCW. Genome-wide association meta-analysis highlights light-induced signaling as a driver for refractive error. Nat Genet. 2018 Jun;50(6):834-848. doi: 10.1038/s41588-018-0127-7. Epub 2018 May 28.
PubMed 29808027Wang W, Jiang Y, Zhu Z, Zhang S, Xuan M, Chen Y, Xiong R, Bulloch G, Zeng J, Morgan IG, He M. Clinically Significant Axial Shortening in Myopic Children After Repeated Low-Level Red Light Therapy: A Retrospective Multicenter Analysis. Ophthalmol Ther. 2023 Apr;12(2):999-1011. doi: 10.1007/s40123-022-00644-2. Epub 2023 Jan 7.
PubMed 36609829Boyer D, Hu A, Warrow D, Xavier S, Gonzalez V, Lad E, Rosen RB, Do D, Schneiderman T, Ho A, Munk MR, Jaffe G, Tedford SE, Croissant CL, Walker M, Ruckert R, Tedford CE. LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the Lumithera Valeda Light Delivery System. Retina. 2024 Mar 1;44(3):487-497. doi: 10.1097/IAE.0000000000003980.
PubMed 37972955Ivandic BT, Ivandic T. Low-level laser therapy improves visual acuity in adolescent and adult patients with amblyopia. Photomed Laser Surg. 2012 Mar;30(3):167-71. doi: 10.1089/pho.2011.3089. Epub 2012 Jan 11.
PubMed 22235969Kaymak H, Munk MR, Tedford SE, Croissant CL, Tedford CE, Ruckert R, Schwahn H. Non-Invasive Treatment of Early Diabetic Macular Edema by Multiwavelength Photobiomodulation with the Valeda Light Delivery System. Clin Ophthalmol. 2023 Nov 22;17:3549-3559. doi: 10.2147/OPTH.S415883. eCollection 2023.
PubMed 38026594Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.
PubMed 25844681Linnik LA, Usov NI, Chechin PP, Pelepchuk OS. [Prospects for using stimulating laser therapy in ophthalmology]. Oftalmol Zh. 1982;37(4):193-7. No abstract available. Russian.
PubMed 7145299
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-Label, Parallel-Group, Randomized Controlled Study Comparing the Dose-Response Relationship of LED Red Light in Controlling Myopia Progression
- ClinicalTrials.gov ID
- NCT07330180
- Acronym / sponsor ID
- 20251009041118960
- Conditions
- Myopia, Myopia, Progressive
- Keywords
- Myopia, Children, Axial Length, Red-light Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Jan 2026 (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 goal of this clinical trial is to verify the effectiveness and safety of non-laser LED red light combined with defocus lens therapy for controlling myopia progression and evaluate the impact of different intervention durations in 6-14 years old children and adolescents with myopia (spherical equivalent refraction: -6.00D ≤ SER ≤ -1.00D), regardless of gender. The main questions it aims to answer are:
[primary hypothesis or outcome measure 1]: Does the combination of Yingtong Vision Rehabilitation Instrument (non-laser LED red light) and Hoya DIMS defocus lens show non-inferior effectiveness to Hoya DIMS defocus lens alone in controlling 6-month axial length change? [primary hypothesis or outcome measure 2]: Do different single intervention durations (2min, 3min, 4min) of non-laser LED red light affect the effectiveness (e.g., axial length change at multiple time points, 12-month SER change) and safety of the combined therapy? If there is a comparison group: Researchers will compare Test Group A (2min PBM therapy + DIMS lenses), Test Group B (3min PBM therapy + DIMS lenses), Test Group C (4min PBM therapy + DIMS lenses), and Control Group D (DIMS lenses alone)] to see if the combined therapy has similar or better myopia control effects and comparable safety, and to identify the optimal intervention duration.
Participants will:
Complete screening examinations (axial length, refractive error, visual acuity, IOP, fundus photography, OCT, etc.) and sign the informed consent form.
Be randomly assigned to one of the four groups and receive the corresponding intervention (use the Yingtong Vision Rehabilitation Instrument as per group-specific duration twice a day, with ≥4-hour interval, plus DIMS lenses; or only DIMS lenses).
Attend regular follow-up visits at 30 days, 3 months, 6 months, 9 months, and 12 months for efficacy and safety assessments (including repeated ocular examinations and adverse event reporting).
Cooperate with the entire 12-month trial process and comply with the device usage specifications and follow-up requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Group A | Experimental | Device: Yingtong Vision Rehabilitation Instrument, Device: Hoya DIMS multi-point myopia defocus lensPBM therapy with single intervention duration of 2 minutes + wearing Hoya DIMS defocus lens |
| Test Group B | Experimental | Device: Yingtong Vision Rehabilitation Instrument, Device: Hoya DIMS multi-point myopia defocus lensPBM therapy with single intervention duration of 3 minutes + wearing Hoya DIMS defocus lens |
| Test Group C | Experimental | Device: Yingtong Vision Rehabilitation Instrument, Device: Hoya DIMS multi-point myopia defocus lensPBM therapy with single intervention duration of 4 minutes + wearing Hoya DIMS defocus lens |
| Control Group D | Active comparator | Device: Hoya DIMS multi-point myopia defocus lensWearing Hoya DIMS defocus lens only |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 6 to 14 years old, regardless of gender;
- After cycloplegic autorefraction, monocular or binocular spherical equivalent refraction (SER) meets: -6.00D ≤ SER ≤ -1.00D, and binocular best-corrected visual acuity (BCVA) ≥ 0.8 (logMAR 0.1; Snellen 20/25);
- Binocular anisometropia ≤ 1.50D; astigmatism ≤ 2.50D;
- Able to understand the purpose of the study, willing to participate in this clinical verification, sign the informed consent form personally or through their legal guardian, and cooperate with the entire trial process (12 months).
Key exclusion criteria (7 listed)
- Photophobia or allergy to cycloplegic agents (e.g., tropicamide or cyclopentolate);
- Received any of the following myopia control measures within one month (including but not limited to): low-concentration atropine eye drops, orthokeratology lenses, myopia control-related frame glasses, low-level red light therapy, defocus soft contact lenses, or defocus RGP lenses;
- Subjects with ocular diseases that may affect visual acuity or refractive error (e.g., lens disorders such as cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, etc.);
- Neurological diseases (previous convulsion history, epilepsy, tic disorders, central nervous system developmental abnormalities) or mental and psychological diseases;
- Systemic diseases: immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function impairment, severe liver and kidney dysfunction, acute or chronic sinusitis, or diabetes mellitus;
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 |
|---|---|---|
| Yingtong Vision Rehabilitation InstrumentInput voltage: 6V (4 × 1.5V alkaline dry batteries). Red light wavelength: 650nm; light spot diameter: outer diameter 5.0mm, inner diameter 1.5mm. Light source output power: 1.6 mW (±0.1mW at 30mm from the observation window). The Yingtong Vision Rehabilitation Instrument should be used twice a day under the regular communication and supervision of hospital optometrists/coordinators (via phone, WeChat, etc.), with an interval of at least 4 hours. | Device | Test Group A, Test Group B, Test Group C |
| Hoya DIMS multi-point myopia defocus lensFrame glasses worn on the bridge of the nose | Device | Control Group D, Test Group A, Test Group B, Test Group C |
Primary outcome
6-month axial length change
Time frame: 6-month
The difference in axial length at 6 months after trial initiation compared with the baseline axial length
2 secondary outcomes
1-, 3-, 9- and 12-month axial length changes
Time frame: 1-, 3-, 9- and 12-month
12-month spherical equivalent refraction (SER) change
Time frame: 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Results publication: PubMed 14985292He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.
- Results publication: PubMed 10764849Zhao J, Pan X, Sui R, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from Shunyi District, China. Am J Ophthalmol. 2000 Apr;129(4):427-35. doi: 10.1016/s0002-9394(99)00452-3.
- Results publication: PubMed 10764851Maul E, Barroso S, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from La Florida, Chile. Am J Ophthalmol. 2000 Apr;129(4):445-54. doi: 10.1016/s0002-9394(99)00454-7.
- Results publication: PubMed 10764850Pokharel GP, Negrel AD, Munoz SR, Ellwein LB. Refractive Error Study in Children: results from Mechi Zone, Nepal. Am J Ophthalmol. 2000 Apr;129(4):436-44. doi: 10.1016/s0002-9394(99)00453-5.
- Results publication: PubMed 17525178Mutti DO, Hayes JR, Mitchell GL, Jones LA, Moeschberger ML, Cotter SA, Kleinstein RN, Manny RE, Twelker JD, Zadnik K; CLEERE Study Group. Refractive error, axial length, and relative peripheral refractive error before and after the onset of myopia. Invest Ophthalmol Vis Sci. 2007 Jun;48(6):2510-9. doi: 10.1167/iovs.06-0562.
- Results publication: PubMed 25837970Zadnik K, Sinnott LT, Cotter SA, Jones-Jordan LA, Kleinstein RN, Manny RE, Twelker JD, Mutti DO; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study Group. Prediction of Juvenile-Onset Myopia. JAMA Ophthalmol. 2015 Jun;133(6):683-9. doi: 10.1001/jamaophthalmol.2015.0471.
- Results publication: PubMed 21330664Zhang M, Gazzard G, Fu Z, Li L, Chen B, Saw SM, Congdon N. Validating the accuracy of a model to predict the onset of myopia in children. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5836-41. doi: 10.1167/iovs.10-5592.
- Results publication: PubMed 19737876Jones-Jordan LA, Sinnott LT, Manny RE, Cotter SA, Kleinstein RN, Mutti DO, Twelker JD, Zadnik K; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study Group. Early childhood refractive error and parental history of myopia as predictors of myopia. Invest Ophthalmol Vis Sci. 2010 Jan;51(1):115-21. doi: 10.1167/iovs.08-3210. Epub 2009 Sep 8.
- Results publication: PubMed 29808027Tedja MS, Wojciechowski R, Hysi PG, Eriksson N, Furlotte NA, Verhoeven VJM, Iglesias AI, Meester-Smoor MA, Tompson SW, Fan Q, Khawaja AP, Cheng CY, Hohn R, Yamashiro K, Wenocur A, Grazal C, Haller T, Metspalu A, Wedenoja J, Jonas JB, Wang YX, Xie J, Mitchell P, Foster PJ, Klein BEK, Klein R, Paterson AD, Hosseini SM, Shah RL, Williams C, Teo YY, Tham YC, Gupta P, Zhao W, Shi Y, Saw WY, Tai ES, Sim XL, Huffman JE, Polasek O, Hayward C, Bencic G, Rudan I, Wilson JF; CREAM Consortium; 23andMe Research Team; UK Biobank Eye and Vision Consortium; Joshi PK, Tsujikawa A, Matsuda F, Whisenhunt KN, Zeller T, van der Spek PJ, Haak R, Meijers-Heijboer H, van Leeuwen EM, Iyengar SK, Lass JH, Hofman A, Rivadeneira F, Uitterlinden AG, Vingerling JR, Lehtimaki T, Raitakari OT, Biino G, Concas MP, Schwantes-An TH, Igo RP Jr, Cuellar-Partida G, Martin NG, Craig JE, Gharahkhani P, Williams KM, Nag A, Rahi JS, Cumberland PM, Delcourt C, Bellenguez C, Ried JS, Bergen AA, Meitinger T, Gieger C, Wong TY, Hewitt AW, Mackey DA, Simpson CL, Pfeiffer N, Parssinen O, Baird PN, Vitart V, Amin N, van Duijn CM, Bailey-Wilson JE, Young TL, Saw SM, Stambolian D, MacGregor S, Guggenheim JA, Tung JY, Hammond CJ, Klaver CCW. Genome-wide association meta-analysis highlights light-induced signaling as a driver for refractive error. Nat Genet. 2018 Jun;50(6):834-848. doi: 10.1038/s41588-018-0127-7. Epub 2018 May 28.
- Results publication: PubMed 36609829Wang W, Jiang Y, Zhu Z, Zhang S, Xuan M, Chen Y, Xiong R, Bulloch G, Zeng J, Morgan IG, He M. Clinically Significant Axial Shortening in Myopic Children After Repeated Low-Level Red Light Therapy: A Retrospective Multicenter Analysis. Ophthalmol Ther. 2023 Apr;12(2):999-1011. doi: 10.1007/s40123-022-00644-2. Epub 2023 Jan 7.
- Results publication: PubMed 37972955Boyer D, Hu A, Warrow D, Xavier S, Gonzalez V, Lad E, Rosen RB, Do D, Schneiderman T, Ho A, Munk MR, Jaffe G, Tedford SE, Croissant CL, Walker M, Ruckert R, Tedford CE. LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the Lumithera Valeda Light Delivery System. Retina. 2024 Mar 1;44(3):487-497. doi: 10.1097/IAE.0000000000003980.
- Results publication: PubMed 22235969Ivandic BT, Ivandic T. Low-level laser therapy improves visual acuity in adolescent and adult patients with amblyopia. Photomed Laser Surg. 2012 Mar;30(3):167-71. doi: 10.1089/pho.2011.3089. Epub 2012 Jan 11.
- Individual participant dataSharing planned: No
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Myopia, Astigmatism
Recruiting
Wavelength Intervention for Nearsighted Kids
Myopia
Not yet recruiting
SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
High Myopia
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yingtong Vision Rehabilitation Instrument and Hoya DIMS multi-point myopia defocus lens in people with Myopia and Myopia, Progressive, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 7 sites 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojuan Wang, Doctor (19537634457, 153803468@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month axial length change (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07330180, which also lists 17 linked publications.
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 9 Jan 2026.