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Trial record 2 of 55903 for:    ELEVATE 1

TGFB1 And LAMA1 Gene Polymorphisms in High Myopia

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ClinicalTrials.gov Identifier: NCT03451877
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Elif Demirkilinc Biler, Ege University

Tracking Information
First Submitted Date  ICMJE February 26, 2018
First Posted Date  ICMJE March 2, 2018
Last Update Posted Date March 5, 2018
Actual Study Start Date  ICMJE December 1, 2012
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
Genetic basis of high myopia [ Time Frame: 4 years ]
evaluated polymorphisms in the LAMA1 (rs2089760) and TGFB1 (rs4803455) genes in children younger than 13 years of age with ≥6 D myopia
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TGFB1 And LAMA1 Gene Polymorphisms in High Myopia
Official Title  ICMJE TGFB1 and LAMA1 Gene Polymorphisms in Turkish Children With High Myopia
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Condition  ICMJE
  • High Myopia
  • Gene Mutations
Intervention  ICMJE Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS
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.
Study Arms  ICMJE
  • Active Comparator: Study group
    Children with cycloplegia refractive error more than -6 D TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined
    Intervention: Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS
  • Control group
    Emmetropic children TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined
    Intervention: Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2018)
151
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2017
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03451877
Other Study ID Numbers  ICMJE 2013-TIP-097
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elif Demirkilinc Biler, Ege University
Study Sponsor  ICMJE Ege University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ege University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP