GlaucomaNCT00727168
Screening for Glaucoma in Namil Area, South Korea
An observational study of Glaucoma and Intraocular Pressure, run by Korean Glaucoma Society at 1 site in South Korea.
Trial summary
The purpose of this study is to study the prevalence of glaucoma in Korea, the investigators selected Namil area in Geumsan city, located in central Korea. The residents aged over 40 in this area are to be recruited to full ophthalmologic examination to detect and classify the glaucoma. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Intraocular Pressure, Optic Nerve Head
- How many people
- 1,532 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to Feb 2008
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All residents aged over 40 in Namil area in Geumsan city
Who may be able to join
- All residents aged over 40 in Namil area
Who cannot join
- Individuals registered but not actually living in this area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiologic Study for the Prevalence of Glaucoma in Namil Area, Geumsan City, South Korea
The purpose of this study is to study the prevalence of glaucoma in Korea, the investigators selected Namil area in Geumsan city, located in central Korea. The residents aged over 40 in this area are to be recruited to full ophthalmologic examination to detect and classify the glaucoma.
Read the detailed description
Screening includes following examinations; Questionaire and Consent form, Visual acuity test, Auto-refraction, IOL Master measurement, Pachymetry, FDT Perimetry, Fundus Photography, Slit lamp examination, Goldmann applanation Tonometry, Gonioscopy, and Binocular optic disc evaluation. For the cases showing any abnormality in FDT perimetry, optic disc morphology, or intraocular pressure, Humphrey automated visual field test is to be performed as an extended examination. Finally, optic nerve head evaluation by OCT or GDx analyzer is to be used as a confirmation test, as well as additional Humphrey visual field test.
- Conditions
- Glaucoma, Intraocular Pressure, Optic Nerve Head, Visual Field
- Keywords
- prevalence study, glaucoma
- Medical subject headings
- Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of glaucoma in Namil area
Measured: cross-sectional
Secondary outcomes (1)
Clinical factors associated with the glaucoma
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Glaucoma Society
- Sponsor type
- Research network
- Investigators
- Gong-je Seong, MD, PhD, Principal investigator, Korean Glaucoma Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727168
- Sponsor's protocol ID
- CNUH81510-9701
- Status last verified
- Aug 2008
- First submitted
- 30 Jul 2008
- Last updated
- 4 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim YY, Lee JH, Ahn MD, Kim CY; Namil Study Group, Korean Glaucoma Society. Angle closure in the Namil study in central South Korea. Arch Ophthalmol. 2012 Sep;130(9):1177-83. doi: 10.1001/archophthalmol.2012.1470.
PubMed 22965594
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study for the Prevalence of Glaucoma in Namil Area, Geumsan City, South Korea
- ClinicalTrials.gov ID
- NCT00727168
- Acronym / sponsor ID
- CNUH81510-9701
- Conditions
- Glaucoma, Intraocular Pressure, Optic Nerve Head, Visual Field
- Keywords
- prevalence study, glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,532 participants (actual)
- Lead sponsor
- Korean Glaucoma SocietyResearch network
- Study start
- Nov 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 1 Aug 2008 (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 study the prevalence of glaucoma in Korea, the investigators selected Namil area in Geumsan city, located in central Korea. The residents aged over 40 in this area are to be recruited to full ophthalmologic examination to detect and classify the glaucoma.
Detailed description
Screening includes following examinations; Questionaire and Consent form, Visual acuity test, Auto-refraction, IOL Master measurement, Pachymetry, FDT Perimetry, Fundus Photography, Slit lamp examination, Goldmann applanation Tonometry, Gonioscopy, and Binocular optic disc evaluation. For the cases showing any abnormality in FDT perimetry, optic disc morphology, or intraocular pressure, Humphrey automated visual field test is to be performed as an extended examination. Finally, optic nerve head evaluation by OCT or GDx analyzer is to be used as a confirmation test, as well as additional Humphrey visual field test.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All residents aged over 40 in Namil area in Geumsan city
Key inclusion criteria (1 listed)
- All residents aged over 40 in Namil area
Key exclusion criteria (1 listed)
- Individuals registered but not actually living in this area
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
Prevalence of glaucoma in Namil area
Time frame: cross-sectional
1 secondary outcome
Clinical factors associated with the glaucoma
Time frame: cross-sectional
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 4 Aug 2008.
- Derived from this study: PubMed 22965594Kim YY, Lee JH, Ahn MD, Kim CY; Namil Study Group, Korean Glaucoma Society. Angle closure in the Namil study in central South Korea. Arch Ophthalmol. 2012 Sep;130(9):1177-83. doi: 10.1001/archophthalmol.2012.1470.
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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.
Gong-je Seong, MD, PhD principal investigator
Korean Glaucoma Society
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 Glaucoma and Intraocular Pressure, run by Korean Glaucoma Society 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: finished, as of the sponsor's last update on 4 Aug 2008. 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?
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?
Prevalence of glaucoma in Namil area (time frame: cross-sectional). 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 NCT00727168, which also lists 1 linked publication.
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 4 Aug 2008.