High MyopiaNCT03451877
TGFB1 And LAMA1 Gene Polymorphisms in High Myopia
A study testing TGFB1 AND LAMA1 GENE POLYMORPHISMS in people with High Myopia and Gene Mutations, run by Ege University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- High Myopia, Gene Mutations
- What is being tested?
- TGFB1 AND LAMA1 GENE POLYMORPHISMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2012to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients under the age of 13
- Patients with cycloplegic refraction values ≥6 D (for study group)
- Emmetropic patients (for control group)
Who cannot join
- Patients who had additional ocular pathology that may affect refraction (such as glaucoma, cataracts, corneal disease)
- Patients with history of ocular surgery
About this study
Official title: TGFB1 and LAMA1 Gene Polymorphisms in Turkish Children With High Myopia
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.
- Conditions
- High Myopia, Gene Mutations
- Being tested
- TGFB1 AND LAMA1 GENE POLYMORPHISMS
- Keywords
- High myopia, TGFB1Gene Polymorphisms, LAMA1 Gene Polymorphisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Children with cycloplegia refractive error more than -6 D TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined Receives: Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS |
| Control group | Other | Emmetropic children TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined Receives: Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Dec 2012
- Primary completion1 Dec 2016
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Demirkilinc Biler, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451877
- Sponsor's protocol ID
- 2013-TIP-097
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2018
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TGFB1 and LAMA1 Gene Polymorphisms in Turkish Children With High Myopia
- ClinicalTrials.gov ID
- NCT03451877
- Acronym / sponsor ID
- 2013-TIP-097
- Conditions
- High Myopia, Gene Mutations
- Keywords
- High myopia, TGFB1Gene Polymorphisms, LAMA1 Gene Polymorphisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMSChildren with cycloplegia refractive error more than -6 D TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined |
| Control group | Other | Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMSEmmetropic children TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients under the age of 13
- Patients with cycloplegic refraction values ≥6 D (for study group)
- Emmetropic patients (for control group)
Key exclusion criteria (2 listed)
- Patients who had additional ocular pathology that may affect refraction (such as glaucoma, cataracts, corneal disease)
- Patients with history of ocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGFB1 AND LAMA1 GENE POLYMORPHISMSwe 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. | Genetic | Control group, Study group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TGFB1 AND LAMA1 GENE POLYMORPHISMS in people with High Myopia and Gene Mutations, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic basis of high myopia (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018; AzTrials last refreshed its copy on 30 Oct 2026.