Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
17. august 2026 opdateret af: Shanghai Eye Disease Prevention and Treatment Center
Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D).
This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high.
Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted defocus incorporated multiple segments (DIMS) based spectacle lens in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
128
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Xiangui He, Prof
- Telefonnummer: +86 15000755422
- E-mail: xianhezi@163.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina
- Shanghai Eye Disease Prevention and Treatment Center
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Kontakt:
- Tianyu Cheng, Dr
- Telefonnummer: +86 18817552005
- E-mail: s70444@126.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age between 3 and 6 years (inclusive), regardless of gender or ethnicity.
- Cycloplegic spherical equivalent refraction (SER) of the worse eye > -0.50 D and ≤ +0.75 D, absolute cylindrical power ≤ 1.0 D, anisometropia ≤ 1.5 D.
- Best corrected monocular distance high contrast VA ≥ 0.5 for ages 3-5; ≥ 0.7 for age 6.
- At least one parent with SER ≤-3.00D
Exclusion Criteria:
- Individuals with any ocular or systemic diseases that may affect vision and refractive development (e.g., keratoconus, abnormalities in lens shape or position, Marfan syndrome, retinopathy of prematurity, etc.).
- Individuals with known allergies or contraindications to cycloplegic agents.
- Previous use of myopia management treatment (spectacles, atropine; CLs).
- Individuals with binocular vision abnormalities: manifest strabismus, monocular suppression, abnormal fusion function, or impaired stereopsis.
- Individuals unable to cooperate with examinations or communicate.
- Any other conditions deemed by the investigator as unsuitable for participation in the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Control group
Wear smartwatches
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Inserted prompt system of the smartwatches can remind the users to go outside.
Inserted sensors can record outdoor parameters such as outdoor time, light intensity, activity pattern, etc.
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Eksperimentel: Intervention group
Wear AI-assisted DIMS-based spectacle lens (at least 10 hours a day), as well as smartwatches
|
Inserted prompt system of the smartwatches can remind the users to go outside.
Inserted sensors can record outdoor parameters such as outdoor time, light intensity, activity pattern, etc.
The AI-DIMS defocus spectacle frame, featuring DIMS-based lenses and an intelligent AI frame, is designed to be worn for at least 10 hours per day.
The frame automatically tracks and records wearing duration parameters.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Changes in axial length
Tidsramme: From baseline to the 12-month follow-up
|
From baseline to the 12-month follow-up
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Changes in Cycloplegic Spherical Equivalent Refraction (SER)
Tidsramme: From baseline to the 12-month follow-up
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From baseline to the 12-month follow-up
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Changes in Choroidal Thickness (CT)
Tidsramme: From baseline to the 12-month follow-up
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From baseline to the 12-month follow-up
|
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Spectacle-wearing compliance and spectacle-wearing time
Tidsramme: From baseline to the 12-month follow-up
|
From baseline to the 12-month follow-up
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Changes in Pupil Diameter
Tidsramme: From baseline to the 12-month follow-up
|
From baseline to the 12-month follow-up
|
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Changes in Intraocular Pressure (IOP)
Tidsramme: From baseline to the 12-month follow-up
|
From baseline to the 12-month follow-up
|
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Changes in Best Corrected Visual Acuity
Tidsramme: From baseline to the 12-month follow-up
|
From baseline to the 12-month follow-up
|
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Adverse event profile
Tidsramme: At 12-month follow-up
|
At 12-month follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: He, Prof, Shanghai Eye Disease Prevention and Treatment Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
12. september 2026
Primær færdiggørelse (Anslået)
31. maj 2028
Studieafslutning (Anslået)
31. august 2028
Datoer for studieregistrering
Først indsendt
11. august 2026
Først indsendt, der opfyldte QC-kriterier
11. august 2026
Først opslået (Faktiske)
14. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIT2026-003-AMD-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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