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The efficacy and safety of 0.01% low concentration atropine sulfate eye drops in delaying the progression of high myopia-a Randomized, double-blind, placebo-controlled, multicenter, 1-year clinical trial.

The efficacy and safety of 0.01% low concentration atropine sulfate eye drops in delaying the progression of high myopia-a Randomized, double-blind, placebo-controlled, multicenter, 1-year clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124233
Enrollment
Unknown
Registered
2026-05-09
Start date
2026-04-22
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

High myopia

Interventions

Control group:0.01% low concentration atropine sulfate eye drops solvent
Experimental group:0.01% low concentration atropine sulfate eye drops

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1.Written informed consent signed by the subject himself and his guardian has been obtained; 2.Subjects aged 15 to 30 years (including the threshold); 3.After cycloplegia, objective refraction was performed to detect the equivalent spherical refraction of both eyes =26.5mm; 4.After cycloplegia, both eyes were measured with objective refraction <=2.50D; 5.Anisometropia (according to equivalent spherical refraction) <=2.50D; 6.Intraocular pressure in both eyes was <21mmHg at the beginning of treatment; 7.Best corrected far visual acuity in both eyes at least 4.9 logarithmic vision (0.8 decimal vision) at the start of treatment;

Exclusion criteria

Exclusion criteria: 1.Subjects who may have eye diseases that affect vision or refractive errors (such as lens damage diseases such as cataracts, glaucoma, macular disease, keratopathy, pigmenitis, retinal detachment, severe vitreous opacity, etc; 2.Systemic diseases: Patients with a history of immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function, and severe liver and kidney dysfunction; 3.Manifest strabismus or any other ocular pathological changes or acute ocular inflammatory diseases in both eyes; 4.Use myopia control therapy in the past, drug therapy: such as atropine or pirenzil equal; For instrument treatment, including orthokeratology, multi-focal soft lens, multi-focal hard lens and functional frame glasses, the continuous washout time before screening was less than three months; Repeated low intensity red light treatment; 5.Systemic or local use of drugs that affect efficacy evaluation within 3 months before screening, such as anticholinines: atropine, pirenzil; Pseudocholines: pilocarpine, etc; 6.Patients who are allergic to atropine, cyclopentostolate and other drugs used in this study; 7.Participants who had participated in other drug clinical trials within 3 months before screening; 8.Other situations deemed unsuitable by the researcher;

Design outcomes

Primary

MeasureTime frame
Spherical equivalent of computer refraction after cycloplegia;

Secondary

MeasureTime frame
Axial length;Safety metrics;

Countries

China

Contacts

Public ContactWang Mengyi

The Zhongshan Ophthalmic Center,Sun Yat-sen University

Ddww904@hotmail.com+86 18600522194

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026