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Short Term Refractive and Ocular Parameter Changes After Topical Atropine

Primary Purpose

Myopia, Left Eye

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
0.125% Atropine
Sponsored by
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Left Eye focused on measuring atropine, cycloplegia, refraction, axial length, anterior chamber depth

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who had an SER of -0.5 diopters or less in their eyes.

Exclusion Criteria:

  • Patients who had already been undergoing cycloplegic treatment for myopia before.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    0.125% atropine group

    Arm Description

    patients used the 0.125 % atropine eyedrop every night before sleep for 7 days

    Outcomes

    Primary Outcome Measures

    SER
    Spherical equivalent refractive error

    Secondary Outcome Measures

    AL
    Axial length
    ACD
    anterior chamber depth
    IOP
    intraocular pressure

    Full Information

    First Posted
    February 10, 2019
    Last Updated
    February 11, 2019
    Sponsor
    Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03839888
    Brief Title
    Short Term Refractive and Ocular Parameter Changes After Topical Atropine
    Official Title
    Short Term Refractive and Ocular Parameter Changes After Topical Atropine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    December 31, 2015 (Actual)
    Study Completion Date
    December 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In order we had designed a prospective clinical trial. Spherical equivalent refractive error (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125% atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated, and their correlations were analyzed with multiple linear regression models.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Left Eye
    Keywords
    atropine, cycloplegia, refraction, axial length, anterior chamber depth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    0.125% atropine group
    Arm Type
    Experimental
    Arm Description
    patients used the 0.125 % atropine eyedrop every night before sleep for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    0.125% Atropine
    Intervention Description
    patients used 0.125% atropine eyedrop per night before sleep for 7 days.
    Primary Outcome Measure Information:
    Title
    SER
    Description
    Spherical equivalent refractive error
    Time Frame
    change from SER at 7 days
    Secondary Outcome Measure Information:
    Title
    AL
    Description
    Axial length
    Time Frame
    change from AL at 7 days
    Title
    ACD
    Description
    anterior chamber depth
    Time Frame
    change from ACD at 7 days
    Title
    IOP
    Description
    intraocular pressure
    Time Frame
    change from IOP at 7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who had an SER of -0.5 diopters or less in their eyes. Exclusion Criteria: Patients who had already been undergoing cycloplegic treatment for myopia before.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32874839
    Citation
    Ho MC, Hsieh YT, Shen EP, Hsu WC, Cheng HC. Short-term refractive and ocular parameter changes after topical atropine. Taiwan J Ophthalmol. 2019 Feb 20;10(2):111-115. doi: 10.4103/tjo.tjo_110_18. eCollection 2020 Apr-Jun.
    Results Reference
    derived

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    Short Term Refractive and Ocular Parameter Changes After Topical Atropine

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