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A randomized, double-blind, placebo-controlled parallel group clinical study of the safety and efficacy of different low concentration atropine sulfate eye drops to reduce Nearwork-induced transient myopia

A randomized, double-blind, placebo-controlled parallel group clinical study of the safety and efficacy of different low concentration atropine sulfate eye drops to reduce Nearwork-induced transient myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043496
Enrollment
Unknown
Registered
2021-02-21
Start date
2021-02-20
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Nearwork-induced transient myopia

Interventions

Trial groups:0.01% atropine eye drops
Trial groups:0.02% atropine eye drops
Trial groups:0.04% atropine eye drops
control group:Atropine sulfate eyedrop vehicle

Sponsors

Shenyang SinQi Eye Hospital Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 15 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all the following criteria to be enrolled in the study. 1. Written informed consent provided by the subject and/or parent/guardian has been obtained. 2. Age 6 to 15 years old, regardless of gender. 3. Eye diopter -0.50 ~ -4.00DS, binocular anisometropia <=1.50DS. 4. Astigmatism <= -1.50DC, and 1/2 of the astigmatism <= spherical lens power. 5. The initial NITM value (according to the equivalent spherical lens power) <=-0.25D. 6. Refractive correction is limited to single focus glasses.

Exclusion criteria

Exclusion criteria: If the subject meets any of the following criteria, they cannot be included in the group: 1. Any person with a history of systemic organic diseases: including diabetes, collagen disease, metabolic disease, immune system disease, severe heart, lung, liver, and kidney dysfunction. 2. Atropine allergy and any systemic diseases and ocular diseases for which atropine drugs are prohibited, such as abnormal heart and lung function, glaucoma, high intraocular pressure and shallow anterior chamber. 3. Anyone with mental illness or mental disorder who cannot have good compliance and cannot follow-up on time. 4. Suffer from any eye diseases that affect vision or affect the refractive system, including corneal diseases, pigment membrane diseases, lens diseases, retinal and optic nerve diseases, anterior chamber inflammatory diseases, vitreous opacity; local inflammatory diseases on the ocular surface, obvious People with dry eyes. 5. Congenital or acquired pupil abnormalities, including abnormal size and abnormal light reflection. 6. Amblyopia, including those whose best corrected visual acuity does not reach 1.0 for other reasons, poor accommodation (range of accommodation lower than the minimum standard for the same age), insufficient aggregation (NPC>15CM), explicit strabismus including intermittent strabismus. 7. Intraocular pressure ?21mmHg, and the difference in intraocular pressure between eyes ?8mmHg. 8. Use drugs that affect the evaluation of curative effect. For example, have used atropine, pirenzepine within 1 month, or used tropicamide and other anticholinergic drugs within 1 week; used pilocarpine and other cholinergic drugs within 1 month. 9. Within 3 months, have used other therapies or drugs that may affect the evaluation of curative effect, wear orthokeratology, Chinese medicine ear point pressing bean therapy, Chinese patent medicine myopia eye drops, etc. 10. Take asthma medications, hormones, antidepressants and other drugs that may affect refractive errors on a regular basis in the past year. 11. Those who have participated in other clinical research within 3 months. 12. Failure to comply with planned visits and other research procedures. 13. Other situations deemed unsuitable by the researcher.

Design outcomes

Primary

MeasureTime frame
Initial NITM value (measured as spherical equivalent);

Secondary

MeasureTime frame
NITM decay time;Equivalent spherical index change (SE);Axial length changes;% progression of equivalent spherical power 1.00d > se = 0.50D;% of equivalent spherical degrees progressed = 1.00 D;

Countries

China

Contacts

Public ContactLei Guo
3073740747@qq.com+86 13940578853

Outcome results

None listed

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