NCT03451877

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
Last Updated

March 5, 2018

Status Verified

March 1, 2018

Enrollment Period

4 years

First QC Date

February 26, 2018

Last Update Submit

March 2, 2018

Conditions

High MyopiaGene Mutations

Keywords

High myopiaTGFB1Gene PolymorphismsLAMA1 Gene Polymorphisms

Outcome Measures

Primary Outcomes (1)

  • 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

    4 years

Study Arms (2)

Study group

ACTIVE COMPARATOR

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

Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS

Control group

OTHER

Emmetropic children TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined

Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS

Interventions

TGFB1 AND LAMA1 GENE POLYMORPHISMSGENETIC

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 groupStudy group

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 2, 2018

Study Start

December 1, 2012

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

March 5, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share