GlaucomaNCT00772993
Efficacy of Retinal Nerve Fiber Layer (RNFL) / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma
An observational study of Glaucoma and Myopia, run by Yonsei University at 1 site in South Korea.
Trial summary
Glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. This assumption has led to the monitoring of the retinal nerve fiber layer thickness for the diagnosis and monitoring of progression of glaucoma. Read more about this study
- Who is it for?
- Ages 10 to 90 yearsHealthy volunteers can take part
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: prospective consecutive recruitment from a tertialry glaucoma subspecialty practise
Who may be able to join
- Primary open angle glaucoma
- Myopia
- Myopia with evidence of glaucoma
- Normal controls
Who cannot join
- Evidence of retinal disease
- BCVA < 0.4
- Secondary glaucoma due to intraocular inflammation
- Lens induced glaucoma
- Tumor induced glaucoma
- Neovascular glaucoma
Trial locations and contacts
1 site in 1 country.
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
Chan Yun Kim, MD,PhD.
About this study
Official title: Efficacy of RNFL / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma
Glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. This assumption has led to the monitoring of the retinal nerve fiber layer thickness for the diagnosis and monitoring of progression of glaucoma. However, varying disc size, myopia and tilted discs affect the thickness of the retinal nerve fiber layer. This study aims to ascertain the ration of the retinal nerve fiber layer against full retina as a predictor of glaucoma diagnosis and progression.
- Keywords
- glaucoma, myopia, myopia with glaucoma, normal control
- Medical subject headings
- Glaucoma, Myopia
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 Control | |
| 3 | Myopia with no evidence of glaucoma | |
| 4 | Myopia with evidence og glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of RNFL / Full thickness retina
Measured: 2 months
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 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
- NCT00772993
- Sponsor's protocol ID
- 4-2008-0340
- 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
- Efficacy of RNFL / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma
- ClinicalTrials.gov ID
- NCT00772993
- Acronym / sponsor ID
- 4-2008-0340
- Keywords
- glaucoma, myopia, myopia with glaucoma, normal control
- 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.
Glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. This assumption has led to the monitoring of the retinal nerve fiber layer thickness for the diagnosis and monitoring of progression of glaucoma. However, varying disc size, myopia and tilted discs affect the thickness of the retinal nerve fiber layer. This study aims to ascertain the ration of the retinal nerve fiber layer against full retina as a predictor of glaucoma diagnosis and progression.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Primary open angle glaucoma |
| 2 | – | –Normal Control |
| 3 | – | –Myopia with no evidence of glaucoma |
| 4 | – | –Myopia with evidence og glaucoma |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- prospective consecutive recruitment from a tertialry glaucoma subspecialty practise
Key inclusion criteria (4 listed)
- Primary open angle glaucoma
- Myopia
- Myopia with evidence of glaucoma
- Normal controls
Key exclusion criteria (6 listed)
- Evidence of retinal disease
- BCVA < 0.4
- Secondary glaucoma due to intraocular inflammation
- Lens induced 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
Ratio of RNFL / Full thickness retina
Time frame: 2 months
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.
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 Myopia, 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 4 inclusion and 6 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?
Ratio of RNFL / Full thickness retina (time frame: 2 months). 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.