Low Concentration Atropine in the Prevention of Myopia in Children.
A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.
1 other identifier
interventional
428
1 country
1
Brief Summary
This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 23, 2023
CompletedFirst Posted
Study publicly available on registry
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJuly 11, 2023
July 1, 2023
1 year
June 23, 2023
July 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative Incidence of Myopia
Effectiveness Evaluation
1 year
Secondary Outcomes (4)
Changes in SE (after cycloplegia)
1 year
Changes in AL
1 year
Changes in visual acuity
1 year
Changes in Choroidal Thickness
1 year
Other Outcomes (5)
Changes in Photophobia Incidence Rate
1 year
Changes in Blurred Vision Incidence Rate
1 year
change in amplitude of accommodation
1 year
- +2 more other outcomes
Study Arms (4)
0.01% atropine
EXPERIMENTAL0.01% atropine eye drop
0.02% atropine
EXPERIMENTAL0.02% atropine eye drop
0.04% atropine
EXPERIMENTAL0.04% atropine eye drop
placebo
PLACEBO COMPARATORplacebo eye drop
Interventions
Eligibility Criteria
You may qualify if:
- The age of the screening stage is 6-9 years, both sexes;
- One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0;
- At least one of parents suffers from myopia (SE of at least one eye \<=-3.00D);
- Parents have signed informed consent and agree to participate in screening and follow-up.
You may not qualify if:
- Parents disagree to sign the informed consent;
- Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery;
- Presence of other eye or systemic diseases;
- Allergies to low concentration atropine or sulfuric acid drugs;
- Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month;
- Presence of other situations that the researchers think is not appropriate for patients to be included in the project.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangui He
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
He Xiangui
Shanghai Eye Disease Prevention and Treatment Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2023
First Posted
July 11, 2023
Study Start
April 1, 2023
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
July 11, 2023
Record last verified: 2023-07