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Trial record 2 of 55326 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

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.


Condition or disease Intervention/treatment Phase
High Myopia Gene Mutations Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: TGFB1 and LAMA1 Gene Polymorphisms in Turkish Children With High Myopia
Actual Study Start Date : December 1, 2012
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Study group
Children with cycloplegia refractive error more than -6 D TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined
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.

Control group
Emmetropic children TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined
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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Elif Demirkilinc Biler, Co-investigator, Ege University
ClinicalTrials.gov Identifier: NCT03451877    
Other Study ID Numbers: 2013-TIP-097
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Elif Demirkilinc Biler, Ege University:
High myopia
TGFB1Gene Polymorphisms
LAMA1 Gene Polymorphisms
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases