Pathological MyopiaNCT00155753
Genomewide Screening of Pathological Myopia
An observational study of Pathological Myopia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the possible candidate gene of pathological myopia Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pathological Myopia
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2002to Aug 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Taiwanese
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, 100
Yung-Feng Shih, MD, 886-2-23123456 ext. 5184, yfshih@ha.mc.ntu.edu.tw
About this study
The purpose of this study is to evaluate the possible candidate gene of pathological myopia
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. Peripheral fundus changes and posterior staphyloma formation are ophthalmoscopic evidences of this process. 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 genetic component to pathologic myopia. Children of myopic parents are more likely to have myopia than are children of nonmyopic parents. The ocular components (axial length, anterior chamber depth, and corneal curvature) and refractive errors of MZ twins are more closely aligned than are those of DZ twins.
Therefore, it is possible to search a potential candidate gene for myopia through the genomic study of pathological myopia.
- Conditions
- Pathological Myopia
- Keywords
- pathological myopia, genomic
- Medical subject headings
- Myopia, Degenerative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological 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
- Enrolment
- 600 participants (estimated)
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 Hospiyal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155753
- Sponsor's protocol ID
- 9100205245
- Status last verified
- Apr 2010
- First submitted
- 9 Sep 2005
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomewide Screening of Pathological Myopia
- ClinicalTrials.gov ID
- NCT00155753
- Acronym / sponsor ID
- 9100205245
- Conditions
- Pathological Myopia
- Keywords
- pathological myopia, genomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 12 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.
The purpose of this study is to evaluate the possible candidate gene of pathological myopia
Detailed description
High myopia (pathological myopia) is caused by excessive axial elongation that primarily involves the ora-equatorial area and the posterior pole. Peripheral fundus changes and posterior staphyloma formation are ophthalmoscopic evidences of this process. 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 genetic component to pathologic myopia. Children of myopic parents are more likely to have myopia than are children of nonmyopic parents. The ocular components (axial length, anterior chamber depth, and corneal curvature) and refractive errors of MZ twins are more closely aligned than are those of DZ twins.
Therefore, it is possible to search a potential candidate gene for myopia through the genomic study of pathological myopia.
Study design
- Observational model
- Case-control
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Taiwanese
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 9 Jun 2010.
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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 Hospiyal
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 Pathological 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 9 Jun 2010. 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 9 Jun 2010.