The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial

NCT04699357 | Completed DMC

• 1 other identifier: SHDC12019111
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 3

Brief Summary

Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control. Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.

Conditions

High Myopia

Outcome Measures

Primary Outcomes (1)

• Changes of spherical equivalent

  Spherical equivalent as measured by cycloplegia autorefraction

  at least 2 years

Secondary Outcomes (5)

• Change in axial length

  at least 2 years

• Best corrected vision acuity (BCVA)

  at least 2 years

• Intraocular pressure (IOP)

  at least 2 years

• Pupil size

  at least 2 years

• Accommodative function

  at least 2 years

Study Arms (3)

Group 1

ACTIVE COMPARATOR

0.01% atropine

Drug: Atropine

Group 2

EXPERIMENTAL

0.04% atropine

Drug: Atropine

Group 3

EXPERIMENTAL

0.1% atropine

Drug: Atropine

Interventions

Atropine DRUG

different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• At least one eye with cycloplegic optometric spherical equivalent of -5.00 to -10.00D and best corrected distant visual acuity of at least 0.5 and near visual acuity of at least 1.0, Titmus Stereo acuity ≤ 80 seconds, Vision with external occultation of ≤ 10 prismatic diopters , vision with internal occultation of ≤ 6-8 prismatic diopters, and astigmatism equal to or less than -2.50D;
• Myopia progression greater than 0.5D in the past year;
• Possess normal cognitive and verbal communication abilities to actively cooperate with the prescribed treatment;
• Written informed consent from the guardian and the child.

You may not qualify if:

• Diseases of the study eye: keratitis, cone cornea, congenital cataract, glaucoma, fundus diseases; combined with inflammation of the anterior or posterior segment of the eye, such as acute conjunctivitis, iridocyclitis;
• Systemic diseases affecting the use of drugs: albinism, epilepsy, severe psychoneurological disorders, congenital heart disease, cardiac arrhythmias;
• Atropine allergy;
• Very low birth weight less than 1500 g;
• Previous treatment with anticholinergics including atropine within the previous 1 year, or use of OK lenses, multifocal soft lenses within 3 months;
• Other conditions judged by the investigator to be unsuitable for participation in the trial.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (3)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai General Hospital

Shanghai, China

Location

Shanghai Ninth People's Hospital

Shanghai, China

Location

MeSH Terms

Interventions

Atropine

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Xun Xu, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: July 4, 2021
• Primary Completion: August 21, 2024
• Study Completion: September 1, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-01

Locations

CN (3)