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TGFB1 And LAMA1 Gene Polymorphisms in High Myopia

Primary Purpose

High Myopia, Gene Mutations

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TGFB1 AND LAMA1 GENE POLYMORPHISMS
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for High Myopia focused on measuring High myopia, TGFB1Gene Polymorphisms, LAMA1 Gene Polymorphisms

Eligibility Criteria

3 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients under the age of 13
  • Patients with cycloplegic refraction values ≥6 D (for study group)
  • Emmetropic patients (for control group)

Exclusion Criteria:

  • Patients who had additional ocular pathology that may affect refraction (such as glaucoma, cataracts, corneal disease)
  • Patients with history of ocular surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Study group

    Control group

    Arm Description

    Children with cycloplegia refractive error more than -6 D TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined

    Emmetropic children TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined

    Outcomes

    Primary Outcome Measures

    Genetic basis of high myopia
    evaluated polymorphisms in the LAMA1 (rs2089760) and TGFB1 (rs4803455) genes in children younger than 13 years of age with ≥6 D myopia

    Secondary Outcome Measures

    Full Information

    First Posted
    February 26, 2018
    Last Updated
    March 2, 2018
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03451877
    Brief Title
    TGFB1 And LAMA1 Gene Polymorphisms in High Myopia
    Official Title
    TGFB1 and LAMA1 Gene Polymorphisms in Turkish Children With High Myopia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2012 (Actual)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    June 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ege University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The investigators aimed to investigate TGFB1 and LAMA1 gene polymorphisms in children with high myopia in order to determine the genetic basis of large myopic shifts causing severe visual impairment and complications. Seventy-four children with high myopia (≥6 diopters [D]; study group) and 77 emmetropic children (±0.5D; control group) were included. Genetic and polymorphism analyses were performed in the Medical Genetics Laboratory using DNA purified from the patients' blood samples.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Myopia, Gene Mutations
    Keywords
    High myopia, TGFB1Gene Polymorphisms, LAMA1 Gene Polymorphisms

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    151 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Active Comparator
    Arm Description
    Children with cycloplegia refractive error more than -6 D TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Emmetropic children TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined
    Intervention Type
    Genetic
    Intervention Name(s)
    TGFB1 AND LAMA1 GENE POLYMORPHISMS
    Intervention Description
    we evaluated polymorphisms in the LAMA1 (rs2089760) and TGFB1 (rs4803455) genes in children younger than 13 years of age with ≥6 D myopia in an attempt to further elucidate the genetic basis of high myopia.
    Primary Outcome Measure Information:
    Title
    Genetic basis of high myopia
    Description
    evaluated polymorphisms in the LAMA1 (rs2089760) and TGFB1 (rs4803455) genes in children younger than 13 years of age with ≥6 D myopia
    Time Frame
    4 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients under the age of 13 Patients with cycloplegic refraction values ≥6 D (for study group) Emmetropic patients (for control group) Exclusion Criteria: Patients who had additional ocular pathology that may affect refraction (such as glaucoma, cataracts, corneal disease) Patients with history of ocular surgery

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    TGFB1 And LAMA1 Gene Polymorphisms in High Myopia

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