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Atropine for Children and Adolescent Myopia Progression Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949101
Recruitment Status : Enrolling by invitation
First Posted : May 14, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Shanghai Eye Disease Prevention and Treatment Center

Brief Summary:
Investigators are going to conduct a randomized controlled trial that myopic children are randomly allocated into two groups: combined use of 1% atropine and 0.01% atropine (experimental group) and 0.01% atropine (control group) in order to explore a better way to control myopia progression and eliminate adverse effects at the same time, provide reliably evidence for clinical guideline of atropine use in children, and investigate the mechanism of atropine on eyes.

Condition or disease Intervention/treatment Phase
Myopia Drug: Atropine Sulfate 1 % Ophthalmic Ointment and Atropine Sulfate 0.01% Eye Drop Drug: atropine 0.01% eye drop Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children are randomly allocated into two groups: combined use of 1% atropine and 0.01% atropine (experimental group) and 0.01% atropine (control group), each group includes 111 children,
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atropine for Children and Adolescent Myopia Progression Study (ACAMP)
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : May 8, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: combined use of 1% atropine and 0.01% atropine
first week, use atropine sulfate 1% ophthalmic ointment every night before sleep; then use atropine sulfate 1% ophthalmic ointment once every week(Friday night before sleep is recommended) for half a year; then use atropine sulfate 0.01% eye drop every night before sleep for one year and a half.
Drug: Atropine Sulfate 1 % Ophthalmic Ointment and Atropine Sulfate 0.01% Eye Drop
use one drop into subconjunctiva

Active Comparator: 0.01% atropine
use atropine sulfate 0.01% eye drop every night before sleep for two years.
Drug: atropine 0.01% eye drop
use one drop into subconjunctiva




Primary Outcome Measures :
  1. spherical equivalent progression in a year [ Time Frame: 2 years ]
    equals sphere +1/2 cylinder

  2. axial length change in a year [ Time Frame: 2 years ]
    measured by IOL-Master


Secondary Outcome Measures :
  1. lens power change in a year [ Time Frame: 2 years ]
    calculated by Bennett-Rabetts formula

  2. choroidal thickness change in a year [ Time Frame: 2 years ]
    measured by SS-OCT

  3. choroidal blood flow density change in a year [ Time Frame: 2 years ]
    measured by OCTA

  4. anterior chamber depth [ Time Frame: 2 years ]
    measured by IOL-Matser

  5. intraocular pressure [ Time Frame: 2 years ]
    measured by a non-contact tonometer

  6. BMI [ Time Frame: 2 years ]
    weight/height^2



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children aged from 7-12 years old;
  • children with spherical equivalent ranged from -0.5D to -6.0D;
  • children without other eye diseases except for ametropia

Exclusion Criteria:

  • children with other eye diseases: amblyopia, strabismus, eye trauma, etc;
  • children with cycloplegia contradictions;
  • children who have used atropine;
  • children who are severly allergic with atropine;
  • children who are using other eye drops for treatment;
  • children with severe heart, lung, liver and kidney diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949101


Locations
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China, Shanghai
Jianfeng Zhu
Shanghai, Shanghai, China, 20040
Sponsors and Collaborators
Shanghai Eye Disease Prevention and Treatment Center
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: Jianfeng Zhu Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  Study Documents (Full-Text)

Documents provided by Shanghai Eye Disease Prevention and Treatment Center:
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Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT03949101    
Other Study ID Numbers: YFZX2019001
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Eye Disease Prevention and Treatment Center:
myopia progression
atropine
prospective study
Additional relevant MeSH terms:
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Myopia
Disease Progression
Disease Attributes
Pathologic Processes
Refractive Errors
Eye Diseases
Atropine
Ophthalmic Solutions
Pharmaceutical Solutions
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action