TGFB1 And LAMA1 Gene Polymorphisms in High Myopia

• Sponsor: Ege University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03451877
• Collaborator: (none)
• Enrollment: 151
• Arms: 2
• Actual Duration (Months): 54

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
High Myopia; Gene Mutations	Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS	N/A

Study Design

• Study Type: Interventional
• 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: Dec 1, 2012
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

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.
Other: 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.

Outcome Measures

Primary Outcome Measures

1. Genetic basis of high myopia [4 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elif Demirkilinc Biler, Co-investigator, Ege University
• ClinicalTrials.gov Identifier: NCT03451877
• Other Study ID Numbers: 2013-TIP-097
• First Posted: Mar 2, 2018
• Last Update Posted: Mar 5, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elif Demirkilinc Biler, Co-investigator, Ege University: High myopia; TGFB1Gene Polymorphisms; LAMA1 Gene Polymorphisms
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Mar 5, 2018