MyopiaNCT00172952
The Role of SNP of ECM and MMP on the Development of Pathological High Myopia
An observational study of Myopia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To study the clinical characteristics and inheritance of pathological myopia in Taiwanese patients. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to Jan 2006
- Phase
- Observational
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- They are unrelated Chinese subjects with high myopia ≦-6.00D. The diagnosis of myopia is determined by the refractive error. Anisometropic individuals, with a refractive error of ≦-6.00 D for one eye and ≦-6.00 D for the other eye, with at least a 2-D difference between the two eyes, are considered unaffected
Who cannot join
- Individuals are excluded if there is known ocular disease or insult that could predispose to myopia, such as retinopathy of prematurity or early-age media opacification, or if they had a known genetic disease associated with myopia, such as Stickler or Marfan syndrome.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yung-Feng Shih, MD, 886-2-23123456 ext. 5184, yfshih@ha.mc.ntu.edu.tw
About this study
Official title: National Taiwan University Hospital
To study the clinical characteristics and inheritance of pathological myopia in Taiwanese patients.
Read the detailed description
High myopia (pathological myopia) is caused by excessive axial elongation that primarily involves the ora-equatorial area and the posterior pole. Pathological myopia often accompanied by glaucoma, cataracts, macular degeneration, and retinal detachment, leading to blindness when the damage to the retina is extremely severe. Population and family studies in Chinese have provided evidence for a geneticcomponent to pathologic myopia. Children of myopic parents are more likely to have myopia than are children of nonmyopic parents. Therefore, it is possible to search a potential candidate gene for myopia through the genomic study of pathological myopia. The retina receives the signal from the retina-RPE complexes and affects the growth of scleral coats. The changes of scleral components, collagen fibrils and proteoglycans, are noted in experimental and human myopia and induce the pathology of high myopia. It is interesting to know that individual difference of SNP in the components of scleral coat affects the response to the signal from retina-RPE complexes. The most important effectors in scleral coats are collagens, proteoglycans, MMPs and TIMPs. Therefore, the difference of SNPs in different genes might contribute the formation of scleral thinning during myopia development. In this project, we will focus on this subject by using GenomeLab SNPstream Genotyping System which is powerful and helpful for identify some specific SNPs in the regard.
- Conditions
- Myopia
- Keywords
- high myopia, genomic
- Medical subject headings
- Myopia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yung-Feng Shih, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172952
- Sponsor's protocol ID
- 9461700339
- Status last verified
- Jun 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taiwan University Hospital
- ClinicalTrials.gov ID
- NCT00172952
- Acronym / sponsor ID
- 9461700339
- Conditions
- Myopia
- Keywords
- high myopia, genomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jan 2006
- First posted
- 15 Sep 2005 (estimated)
- 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.
To study the clinical characteristics and inheritance of pathological myopia in Taiwanese patients.
Detailed description
High myopia (pathological myopia) is caused by excessive axial elongation that primarily involves the ora-equatorial area and the posterior pole. Pathological myopia often accompanied by glaucoma, cataracts, macular degeneration, and retinal detachment, leading to blindness when the damage to the retina is extremely severe. Population and family studies in Chinese have provided evidence for a geneticcomponent to pathologic myopia. Children of myopic parents are more likely to have myopia than are children of nonmyopic parents. Therefore, it is possible to search a potential candidate gene for myopia through the genomic study of pathological myopia. The retina receives the signal from the retina-RPE complexes and affects the growth of scleral coats. The changes of scleral components, collagen fibrils and proteoglycans, are noted in experimental and human myopia and induce the pathology of high myopia. It is interesting to know that individual difference of SNP in the components of scleral coat affects the response to the signal from retina-RPE complexes. The most important effectors in scleral coats are collagens, proteoglycans, MMPs and TIMPs. Therefore, the difference of SNPs in different genes might contribute the formation of scleral thinning during myopia development. In this project, we will focus on this subject by using GenomeLab SNPstream Genotyping System which is powerful and helpful for identify some specific SNPs in the regard.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- They are unrelated Chinese subjects with high myopia ≦-6.00D. The diagnosis of myopia is determined by the refractive error. Anisometropic individuals, with a refractive error of ≦-6.00 D for one eye and ≦-6.00 D for the other eye, with at least a 2-D difference between the two eyes, are considered unaffected
Key exclusion criteria (1 listed)
- Individuals are excluded if there is known ocular disease or insult that could predispose to myopia, such as retinopathy of prematurity or early-age media opacification, or if they had a known genetic disease associated with myopia, such as Stickler or Marfan syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Yung-Feng Shih, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yung-Feng Shih, MD (886-2-23123456 ext. 5184, yfshih@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Sep 2005.