GlaucomaNCT00742378
Discriminating Ability of the Cirrus High Definition (HD) Optical Coherence Tomography (OCT) for Glaucoma
An observational study of Glaucoma, run by Yonsei University at 1 site in South Korea.
Trial summary
The Cirrus HD OCT, a new spectral domain optical coherence tomography, has better resolution than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for glaucoma detection will be studied. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Glaucoma patients and normal controls
Who may be able to join
- Cooperative patients
- Repeated OCT data
Who cannot join
- Intraocular surgeries history
- DM
- High refractive error ( < -4.00 diopters, or > + 4.00 diopters)
- Media opacity
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gong Je Seong
Seoul, 135-720
Gong Je Seong, MD, PhD, 82-2-2019-3441, gjseong@yuhs.ac
Gong Je Seong, MD, PhD
About this study
Official title: Discriminating Ability of the Cirrus HD OCT for Glaucoma
The Cirrus HD OCT, a new spectral domain optical coherence tomography, has better resolution than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for glaucoma detection will be studied.
Read the detailed description
The Cirrus HD OCT is a newly developed imaging device of the spectral domain optical coherence tomography. Even though its resolution and speed are much better than the previous OCT, its reproducibility and diagnostic power for detecting the glaucomatous defect of retinal nerve fiber layer (RNFL) have not known yet. In the present study, we will review the data of RNFL thickness measurement using the Cirrus HD OCT. After assessing the inter-test variability, the discriminating ability of the Cirrus HD OCT for glaucoma diagnosis will be determined by the ROC curves.
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Retinal nerve fiber layer, Cirrus OCT
- Medical subject headings
- Glaucoma
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 |
|---|---|---|
| C | Normal controls | |
| G | Glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal nerve fiber layer thickness
Measured: when the OCT images are taking
Secondary outcomes (3)
Red-free fundus photo
Measured: when the OCT images are taking
Visual field
Measured: when the OCT images are taking
Intraocular pressure
Measured: when the OCT images are taking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionOct 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Gong Je Seong, MD, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742378
- Sponsor's protocol ID
- 3-2008-0076-Reproducibility
- Status last verified
- Sep 2008
- First submitted
- 26 Aug 2008
- Last updated
- 23 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discriminating Ability of the Cirrus HD OCT for Glaucoma
- ClinicalTrials.gov ID
- NCT00742378
- Acronym / sponsor ID
- 3-2008-0076-Reproducibility
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Retinal nerve fiber layer, Cirrus OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 27 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 Cirrus HD OCT, a new spectral domain optical coherence tomography, has better resolution than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for glaucoma detection will be studied.
Detailed description
The Cirrus HD OCT is a newly developed imaging device of the spectral domain optical coherence tomography. Even though its resolution and speed are much better than the previous OCT, its reproducibility and diagnostic power for detecting the glaucomatous defect of retinal nerve fiber layer (RNFL) have not known yet. In the present study, we will review the data of RNFL thickness measurement using the Cirrus HD OCT. After assessing the inter-test variability, the discriminating ability of the Cirrus HD OCT for glaucoma diagnosis will be determined by the ROC curves.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C | – | –Normal controls |
| G | – | –Glaucoma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients and normal controls
Key inclusion criteria (2 listed)
- Cooperative patients
- Repeated OCT data
Key exclusion criteria (4 listed)
- Intraocular surgeries history
- DM
- High refractive error ( < -4.00 diopters, or > + 4.00 diopters)
- Media opacity
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
Retinal nerve fiber layer thickness
Time frame: when the OCT images are taking
3 secondary outcomes
Red-free fundus photo
Time frame: when the OCT images are taking
Visual field
Time frame: when the OCT images are taking
Intraocular pressure
Time frame: when the OCT images are taking
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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.
Gong Je Seong, MD, PhD principal investigator
Yonsei University
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, 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 2 inclusion and 4 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 23 Sep 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 Gong Je Seong, MD, PhD (82-2-2019-3441, gjseong@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fiber layer thickness (time frame: when the OCT images are taking). 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 23 Sep 2008.