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Myopia Progression and the Effect of 7-Methylxanthine

Primary Purpose

Myopia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
7-methylxanthine
Sponsored by
Trier Research Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year. - Exclusion Criteria: Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma) -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Axial growth

    Secondary Outcome Measures

    Myopia progression

    Full Information

    First Posted
    December 6, 2005
    Last Updated
    December 13, 2005
    Sponsor
    Trier Research Laboratories
    Collaborators
    Generalkonsul Einar Høyvalds Fond, Jørgen Bagenkop Nielsens Myopi-Fond, Chr. Andersen og hustru Ingeborg Andersen, f. Schmidts legat (fond) oprettet af deres datter, frk. Lilli Ellen Andersen.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00263471
    Brief Title
    Myopia Progression and the Effect of 7-Methylxanthine
    Official Title
    Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2003
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Trier Research Laboratories
    Collaborators
    Generalkonsul Einar Høyvalds Fond, Jørgen Bagenkop Nielsens Myopi-Fond, Chr. Andersen og hustru Ingeborg Andersen, f. Schmidts legat (fond) oprettet af deres datter, frk. Lilli Ellen Andersen.

    4. Oversight

    5. Study Description

    Brief Summary
    7-methylxanthine has been shown to increase the concentration and thickness of collagen fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize the sclera and prevent further progression of myopia.
    Detailed Description
    Participants are given tablets of 7-methylxanthine 400 mg per day or placebo tablets for 12 months. Axial length, cycloplegic refraction and corneal curvature is measured, as well as weight, height, blood pressure and heart rate. The participants are interviewed about possible CNS, gastrointestinal, or cardiopulmonal side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    90 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    7-methylxanthine
    Primary Outcome Measure Information:
    Title
    Axial growth
    Secondary Outcome Measure Information:
    Title
    Myopia progression

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year. - Exclusion Criteria: Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma) -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Klaus Trier, MD
    Organizational Affiliation
    Trier Research Laboratories
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10574816
    Citation
    Trier K, Olsen EB, Kobayashi T, Ribel-Madsen SM. Biochemical and ultrastructural changes in rabbit sclera after treatment with 7-methylxanthine, theobromine, acetazolamide, or L-ornithine. Br J Ophthalmol. 1999 Dec;83(12):1370-5. doi: 10.1136/bjo.83.12.1370.
    Results Reference
    background
    PubMed Identifier
    23380471
    Citation
    Cui D, Trier K, Munk Ribel-Madsen S. Effect of day length on eye growth, myopia progression, and change of corneal power in myopic children. Ophthalmology. 2013 May;120(5):1074-9. doi: 10.1016/j.ophtha.2012.10.022. Epub 2013 Feb 4.
    Results Reference
    derived

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    Myopia Progression and the Effect of 7-Methylxanthine

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