Glaucoma PatientcirrusOCTNCT01067482
The Performances of Spectral Domain Optical Coherence Tomography (OCT) for Distinguishing Glaucomatous Eyes
An observational study of Glaucoma Patient and Glaucoma Suspect Patient, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate performances of each parameters of spectral domain (Cirrus) optical coherence tomography for distinguishing between normal eyes, glaucoma suspect and glaucomatous eyes Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Patient, Glaucoma Suspect Patient, Normal Population
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2009to Mar 2010
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: glaucoma patient from glaucoma clinic that is POAG Glaucoma suspect cases normal population case
Who may be able to join
- BCVA at least 20/60
- refractive error +/- 5 D Or astig +/- 3 D
- enrolled in 3 population group (glaucoma, glaucoma suspect or normal)
Who cannot join
- VA less than 20/60
- marked RF error
- previous ocular trauma or surgery
- unreliable visual field
- poor signal cirrus OCT (less than 7)
- other causes of optic nerve or macular disease other than glaucoma
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University
Hat Yai, Songkhla, Thailand., 90110
About this study
Official title: The Performances of Spectral Domain Optical Coherence Tomography for Distinguishing Between Normal Eyes, Glaucoma Suspect and Glaucomatous Eyes
The purpose of this study is to evaluate performances of each parameters of spectral domain (Cirrus) optical coherence tomography for distinguishing between normal eyes, glaucoma suspect and glaucomatous eyes
Read the detailed description
Aim to determine which parameter of cirrus OCT is best sensitivity and specificity for glaucoma detection
- Conditions
- Glaucoma Patient, Glaucoma Suspect Patient, Normal Population, RNFL Thickness by Location, Macular Thickness by Location
- Keywords
- OCT, spectral domain cirrus, glaucoma, glaucoma suspect, normal population
- Medical subject headings
- Glaucoma, Ocular Hypertension
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 |
|---|---|---|
| Glaucoma patients | Not described | |
| Glaucoma suspect group | Not described | |
| Normal population | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma PatientStudies 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
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Investigators
- Weerawat Kiddee, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067482
- Sponsor's protocol ID
- EC 52-336-02-1-2
- Acronym
- cirrusOCT
- Status last verified
- Oct 2009
- First submitted
- 10 Feb 2010
- Last updated
- 23 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performances of Spectral Domain Optical Coherence Tomography for Distinguishing Between Normal Eyes, Glaucoma Suspect and Glaucomatous Eyes
- ClinicalTrials.gov ID
- NCT01067482
- Acronym / sponsor ID
- cirrusOCT / EC 52-336-02-1-2
- Conditions
- Glaucoma Patient, Glaucoma Suspect Patient, Normal Population, RNFL Thickness by Location, Macular Thickness by Location
- Keywords
- OCT, spectral domain cirrus, glaucoma, glaucoma suspect, normal population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Feb 2010 (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 evaluate performances of each parameters of spectral domain (Cirrus) optical coherence tomography for distinguishing between normal eyes, glaucoma suspect and glaucomatous eyes
Detailed description
Aim to determine which parameter of cirrus OCT is best sensitivity and specificity for glaucoma detection
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glaucoma patients | – | – |
| Glaucoma suspect group | – | – |
| Normal population | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma patient from glaucoma clinic that is POAG Glaucoma suspect cases normal population case
Key inclusion criteria (3 listed)
- BCVA at least 20/60
- refractive error +/- 5 D Or astig +/- 3 D
- enrolled in 3 population group (glaucoma, glaucoma suspect or normal)
Key exclusion criteria (6 listed)
- VA less than 20/60
- marked RF error
- previous ocular trauma or surgery
- unreliable visual field
- poor signal cirrus OCT (less than 7)
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
Not reported in the source record.
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 23 Mar 2010.
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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.
Weerawat Kiddee, MD principal investigator
Prince of Songkla 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 Patient and Glaucoma Suspect Patient, run by Prince of Songkla University at 1 site in Thailand.
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 3 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: finished, as of the sponsor's last update on 23 Mar 2010. 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 Thailand. 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.
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 Mar 2010.