Glaucoma Patients and Healthy ControlsNCT01299233
Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3
An observational study of Glaucoma Patients and Healthy Controls, run by University of Zurich at 1 site in Switzerland.
Trial summary
To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Patients and Healthy Controls
- What is being tested?
- Spectralis® SD-OCT, Heidelberg Engineering GmbH, H
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2011to Dec 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients and controls are selected out of our primary care clinic
Who may be able to join
- for both groups (glaucoma study group and control group): men and women of at least 50 years of age
- for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)
Who cannot join
- for both groups (glaucoma study group and control group):
- less then 18 years of age
- any pathology of the central retina
- any optic nerve disorder other then glaucoma
- retinal vascular disorder
- for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma
- for the control group: any diagnosis of glaucoma
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Ophthalmic Clinic
Zurich, Canton of Zurich, 8091
About this study
To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements.
- Trial with medical device
- Conditions
- Glaucoma Patients and Healthy Controls
- Being tested
- Spectralis® SD-OCT, Heidelberg Engineering GmbH, H
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectralis® SD-OCT, Heidelberg Engineering GmbH, HDevice
Measurement of the peripapillar nerve fiber layer with different settings of ART
| Study group | Role | What they receive |
|---|---|---|
| control group | age matched healthy controls Receives: Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H | |
| Glaucoma | patients with diagnosis of primary open angle glaucoma Receives: Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H |
What is being measured
The primary outcome is the main question the study is designed to answer.
COV
Measured: T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma Patients and Healthy ControlsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Funk, Prof. MD, Principal investigator, University Hospital Zurich, Ophtalmic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299233
- Sponsor's protocol ID
- ART-OCT
- Status last verified
- Dec 2014
- First submitted
- 16 Feb 2011
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3
- ClinicalTrials.gov ID
- NCT01299233
- Acronym / sponsor ID
- ART-OCT
- Conditions
- Glaucoma Patients and Healthy Controls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Feb 2011 (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.
To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements.
- Trial with medical device
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, Hage matched healthy controls |
| Glaucoma | – | Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, Hpatients with diagnosis of primary open angle glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients and controls are selected out of our primary care clinic
Key inclusion criteria (2 listed)
- for both groups (glaucoma study group and control group): men and women of at least 50 years of age
- for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)
Key exclusion criteria (7 listed)
- less then 18 years of age
- any pathology of the central retina
- any optic nerve disorder other then glaucoma
- retinal vascular disorder
- for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectralis® SD-OCT, Heidelberg Engineering GmbH, HMeasurement of the peripapillar nerve fiber layer with different settings of ART | Device | Glaucoma, control group |
Primary outcome
COV
Time frame: T0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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.
Jens Funk, Prof. MD principal investigator
University Hospital Zurich, Ophtalmic Clinic
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 Patients and Healthy Controls, run by University of Zurich at 1 site in Switzerland.
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 7 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 6 Jan 2015. 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 Switzerland. 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?
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?
COV (time frame: T0). 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 6 Jan 2015.