Efficacy and safety of 0.004% atropine sulfate eye drops on juvenile pre-myopia: A randomized, double-blind, placebo-controlled clinical trial

Efficacy and safety of atropine sulfate eye drops (II) on juvenile pre-myopia: A randomized, double-blind, placebo-controlled clinical trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200056436

Enrollment

Unknown

Registered

2022-02-06

Start date

2022-02-14

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

pre-myopia

Interventions

Atropine treatment group:Atropine sulfate eye drops (II), once a night

Placebo control group:Atropine sulfate eye drops (II) vehicle placebo, once a night

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 6 and 12 years old; 2. Binocular naked vision >= 1.0; 3. Computerized optometry se - 0.50 d after ciliary muscle paralysis; 4. Selection of study eyes: if both eyes are qualified, select the eyes with small diopter as the study eyes; If the diopters of both eyes are equal, select the left eye as the study eye; 5. Informed consent, and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Cylinder degree of both eye or study eye > 1.50D; Binocular refractive difference > 1.50D; 2. Strabismus; 3. The far-range and short-range latent strabismus is not within the range of - 12 to + 6 prismatic degrees; 4. Binocular or monocular organic diseases affecting vision, such as corneal, iris, lens and fundus diseases; 5. Those who have used orthokeratology lens, hard corneal contact lens, progressive multifocal glasses, peripheral defocus control lens, multifocal soft contact lenses, external treatment of traditional Chinese medicine (including acupuncture, electroacupuncture, massage, moxibustion, pressing beans at ear points, etc.), low concentration atropine eye drops, visual training or other related treatments six months before enrollment; 6. Patients with serious systemic diseases, such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system or mental diseases; Allergic constitution or allergic to atropine sulfate, cyclopentate or eye drops excipients; Or psychotic subjects; 7. Those who are participating in other clinical trials; 8. Those who meet the inclusion criteria but can not adhere to the treatment and are easy to lose follow-up.

Design outcomes

Primary

Measure	Time frame
Spherical equivalent;Axial length;	—

Secondary

Measure	Time frame
Anterior chamber depth;Lens Thickness;Vitreous depth;Vital signs;Best corrected visual acuity;Adjust flexibility;Slit lamp inspection;	—

Countries

China

Contacts

Public ContactHan Huifang

Hebei Eye Hospital

xtykyyhhf@163.com+86 15631901732

Outcome results

None listed

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