Pseudoexfoliation SyndromeNCT01515735
LOXL1 Polymorphism in Pseudoexfoliation Syndrome
An observational study of Pseudoexfoliation Syndrome, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with pseudoexfoliation syndrome in the Korean population, Genotypes of lysyl oxidase-like 1 gene were analyzed by direct sequencing. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pseudoexfoliation Syndrome
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Dec 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the groups or cohorts will be recruited from glaucoma clinic in Samsung medical center
Who may be able to join
- Clinical diagnosis of Pseudoexfoliation
Who cannot join
- medical condition that peripheral blood sampling cannot be done
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung medical center
Seoul, 135710
Changwon Kee, M.D., Ph.D, 82-2-3410-3564, ckee@skku.edu
changwon Kee, M.D., Ph.D
About this study
Official title: Evaluation of LOXL1 Polymorphism in Pseudoexfoliation Syndrome in the Korean Population
To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with pseudoexfoliation syndrome in the Korean population, Genotypes of lysyl oxidase-like 1 gene were analyzed by direct sequencing.
Read the detailed description
To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with pseudoexfoliation syndrome in the Korean population, peripheral blood sampling will be done from the patients with pseudoexfoliation.
And genotypes of the three single nucleotide polymorphisms of lysyl oxidase-like 1 gene , rs1048661, rs3825942, rs2165241 were analyzed by direct sequencing.
- Conditions
- Pseudoexfoliation Syndrome
- Medical subject headings
- Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pseudoexfoliation | The study group composted of the patients with pseudoexfoliation syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotypes of the three single nucleotide polymorphisms of LOXL1 (rs1048661, rs3825942, rs2165241)
Genotypes of the three single nucleotide polymorphisms of LOXL1 were analyzed by direct sequencing, after obtained from the peripheral blood sampling from patients.
Measured: about 1 year (when all patients were recruited)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pseudoexfoliation SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changwon Kee, M.D., PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515735
- Sponsor's protocol ID
- 2011-06-035
- Status last verified
- Jan 2012
- First submitted
- 18 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mori K, Imai K, Matsuda A, Ikeda Y, Naruse S, Hitora-Takeshita H, Nakano M, Taniguchi T, Omi N, Tashiro K, Kinoshita S. LOXL1 genetic polymorphisms are associated with exfoliation glaucoma in the Japanese population. Mol Vis. 2008 Jun 5;14:1037-40.
PubMed 18552979Fuse N, Miyazawa A, Nakazawa T, Mengkegale M, Otomo T, Nishida K. Evaluation of LOXL1 polymorphisms in eyes with exfoliation glaucoma in Japanese. Mol Vis. 2008 Jul 21;14:1338-43.
PubMed 18648524
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of LOXL1 Polymorphism in Pseudoexfoliation Syndrome in the Korean Population
- ClinicalTrials.gov ID
- NCT01515735
- Acronym / sponsor ID
- 2011-06-035
- Conditions
- Pseudoexfoliation Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 24 Jan 2012 (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 evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with pseudoexfoliation syndrome in the Korean population, Genotypes of lysyl oxidase-like 1 gene were analyzed by direct sequencing.
Detailed description
To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with pseudoexfoliation syndrome in the Korean population, peripheral blood sampling will be done from the patients with pseudoexfoliation.
And genotypes of the three single nucleotide polymorphisms of lysyl oxidase-like 1 gene , rs1048661, rs3825942, rs2165241 were analyzed by direct sequencing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pseudoexfoliation | – | –The study group composted of the patients with pseudoexfoliation syndrome |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the groups or cohorts will be recruited from glaucoma clinic in Samsung medical center
Key inclusion criteria (1 listed)
- Clinical diagnosis of Pseudoexfoliation
Key exclusion criteria (1 listed)
- medical condition that peripheral blood sampling cannot be done
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
Genotypes of the three single nucleotide polymorphisms of LOXL1 (rs1048661, rs3825942, rs2165241)
Time frame: about 1 year (when all patients were recruited)
Genotypes of the three single nucleotide polymorphisms of LOXL1 were analyzed by direct sequencing, after obtained from the peripheral blood sampling from patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
- Results publication: PubMed 18552979Mori K, Imai K, Matsuda A, Ikeda Y, Naruse S, Hitora-Takeshita H, Nakano M, Taniguchi T, Omi N, Tashiro K, Kinoshita S. LOXL1 genetic polymorphisms are associated with exfoliation glaucoma in the Japanese population. Mol Vis. 2008 Jun 5;14:1037-40.
- Results publication: PubMed 18648524Fuse N, Miyazawa A, Nakazawa T, Mengkegale M, Otomo T, Nishida K. Evaluation of LOXL1 polymorphisms in eyes with exfoliation glaucoma in Japanese. Mol Vis. 2008 Jul 21;14:1338-43.
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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.
Changwon Kee, M.D., PhD study chair
Samsung Medical Center
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 Pseudoexfoliation Syndrome, run by Samsung Medical Center at 1 site in South Korea.
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 24 Jan 2012. 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 South Korea. 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 Changwon Kee, M.D., Ph.D. (82-2-3410-3564, ckee@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotypes of the three single nucleotide polymorphisms of LOXL1 (rs1048661, rs3825942, rs2165241) (time frame: about 1 year (when all patients were recruited)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01515735, which also lists 2 linked publications.
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 24 Jan 2012.