Primary Open Angle GlaucomaNCT00773877
Comparison of Retinal Nerve Fiber Layer (RNFL) Thickness Measurements by Time-Domain and Spectral-Domain OCT In Glaucoma Patients
An observational study of Primary Open Angle Glaucoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Measurement of RNFL thickness by OCT is at a cornerstone for the correct diagnosis and monitoring of progression of glaucomatous optic neuropathy. Spectral domain technology has enabled better reproducibility with better axial resolution in the measurement of RNFL thickness. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2008to Dec 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary open angle glaucoma
Who may be able to join
None listed.
Who cannot join
- Evidence of retinal disease
- Secondary glaucoma due to intraocular inflammation
- Lens induced glaucoma
- Neovascular glaucoma
- Tumor induced glaucoma
Trial locations and contacts
1 site in 1 country.
Sung Yong Kang, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University School of Medicine
Seoul, 120-752
Chan Yun Kim, MD,PhD, 82-2-2228-3570, kangeye@hotmail.com
Sung Yong Kang, MD, 82-2-2228-3570, kangeye@yuhs.ac
About this study
Official title: Comparison of RNFL Thickness Measurements by Time-Domain and Spectral-Domain OCT In Glaucoma Patients
Measurement of RNFL thickness by OCT is at a cornerstone for the correct diagnosis and monitoring of progression of glaucomatous optic neuropathy.
Spectral domain technology has enabled better reproducibility with better axial resolution in the measurement of RNFL thickness. A comparative study among Stratus, Cirrus and RT-View will enable clinicians to determine differences among various instruments.
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- RNFL thickness
- Medical subject headings
- Glaucoma, Open-Angle
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 |
|---|---|---|
| 1 | Primary open angle glaucoma | |
| 2 | Normal Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNFL thickness
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773877
- Sponsor's protocol ID
- 4-2008-0342
- Status last verified
- Oct 2008
- First submitted
- 15 Oct 2008
- Last updated
- 16 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of RNFL Thickness Measurements by Time-Domain and Spectral-Domain OCT In Glaucoma Patients
- ClinicalTrials.gov ID
- NCT00773877
- Acronym / sponsor ID
- 4-2008-0342
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- RNFL thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 16 Oct 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.
Measurement of RNFL thickness by OCT is at a cornerstone for the correct diagnosis and monitoring of progression of glaucomatous optic neuropathy.
Spectral domain technology has enabled better reproducibility with better axial resolution in the measurement of RNFL thickness. A comparative study among Stratus, Cirrus and RT-View will enable clinicians to determine differences among various instruments.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Primary open angle glaucoma |
| 2 | – | –Normal Controls |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary open angle glaucoma
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Evidence of retinal disease
- Secondary glaucoma due to intraocular inflammation
- Lens induced glaucoma
- Neovascular glaucoma
- Tumor induced glaucoma
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
RNFL thickness
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2008.
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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.
Sung Yong Kang, MD contact
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 Primary Open Angle Glaucoma, run by Yonsei University 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 0 inclusion and 5 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 16 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chan Yun Kim, MD,PhD (82-2-2228-3570, kangeye@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RNFL thickness (time frame: 1 month). 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 16 Oct 2008.