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Efficacy and safety of low energy laser combined with low concentration atropine for controlling high myopia in young children

Efficacy and safety of low energy laser combined with low concentration atropine for controlling high myopia in young children

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037235
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High myopia in children

Interventions

control group:0.01%atropine
Intervention group:Low energy laser therapy+0.01%atropine

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age ranged from 6 to 12 years. Sex is not limited; 2. Diagnosis of myopic ametropia in any eye; after mydriasis, the myopia spherical lens is more than 4.00D, astigmatism < 2.00D, anisometropia < 3.00D; the best corrected visual acuity was at least 0.8, and the near visual acuity was at least 1.0; 3. Having normal thinking and language communication skills, being able to cooperate with the treatment actively; 4. No contraindications of atropine therapy. No acute ocular inflammation, dry eye, keratoconus, and diabetes; 5. Informed consent signed by guardians and children.

Exclusion criteria

Exclusion criteria: 1. History of photoallergy, glaucoma, glaucomatocyclitis, ocular hypertension, macular lesions or injuries 2. High myopiawith leopard like changes in fundus retina; 3. Combined with heart, liver, kidney and other systemic diseases and congenital hereditary myopia; 4. Combined with ocular injuries, strabismusoperated eyes, allergic conjunctivitis and other chronic eye diseases; 5. Pre-existing entropion, trichiasis, serious keratoconjunctival infection and other eye diseases; 6. Patients with nervous system diseases and allergy or contraindications to atropine or other therapeutic drugs; 7. Patients with immune system and systemic diseases such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, diabetes, etc; 8. Epilepsy, mental disorders, unable to communicate normally; 9. Having received other treatments to control the development of myopia; 10. Other situations that are judged by the researcher to be unsuitable to participate in the research.

Design outcomes

Primary

MeasureTime frame
myopic refraction;

Countries

China

Contacts

Public ContactYan Yu

Shanghai Eye Disease Prevention and Treatment Center

drxuyan_2004@163.com+86 18621080996

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026