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Completed

NCT Number: NCT04699357

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

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.

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Key information

Conditions

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Eye Disease Prevention & Treatment Center, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Atropine

Drug

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

Primary outcomes

  1. Changes of spherical equivalent

    Time frame: at least 2 years

    Spherical equivalent as measured by cycloplegia autorefraction

Secondary outcomes

  1. Change in axial length

    Time frame: at least 2 years

    AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster or Lenstar

  2. Best corrected vision acuity (BCVA)

    Time frame: at least 2 years

    BCVA were measured at 4 meters by trained optometrists using the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart

  3. Intraocular pressure (IOP)

    Time frame: at least 2 years

    Intraocular pressure (IOP) is measured using a non-contact tonometer, with the average of three consecutive measurements taken.

  4. Pupil size

    Time frame: at least 2 years

    Photopic and mesopic pupil diameters were measured using a handheld device (VIP-300, NeurOptics) after a 2-minute light adaptation and a 5-minute dark adaptation, respectively

  5. Accommodative function

    Time frame: at least 2 years

    Positive/negative relative accommodation (PRA/NRA) were performed at a distance of 40 cm

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

Shanghai Eye Disease Prevention and Treatment Center

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 7, 2021
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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