Glaucoma Patients and Healthy ControlsPhase 4NCT01273285
Reproducibility of Nerve Fiber Layer Thickness Measurements in Patients With Glaucoma and Healthy Controls Using Spectral-Domain and Time-Domain OCT
A Phase 4 study testing Spectralis® SD-OCT, Heidelberg Engineering GmbH, H in people with Glaucoma Patients and Healthy Controls, run by University of Zurich at 1 site in Switzerland.
Trial summary
To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and to compare these results to conventional Time-Domain-OCT (TD-OCT). Trial with medical device Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2009to Mar 2010
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18yo or older, healthy
- glaucom group: age 18yo or older, diagnosis of primary open angle glaucoma (POAG)
- Exclusion criteria: Exclusion criteria in the control group were history of glaucoma, history of any other ocular disease, or intraocular pressure greater than 21mmHg. Exclusion criteria in the glaucoma group were history of other optic neuropathies.
- or severe optic media opacities.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and to compare these results to conventional Time-Domain-OCT (TD-OCT).
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
reproducibility of retinal nerve fiber layer thickness measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startApr 2009
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273285
- Sponsor's protocol ID
- RNFL-Repro
- Status last verified
- Jan 2011
- First submitted
- 7 Jan 2011
- Last updated
- 10 Jan 2011
- Results posted
- No
Publications
Toteberg-Harms M, Sturm V, Knecht PB, Funk J, Menke MN. Repeatability of nerve fiber layer thickness measurements in patients with glaucoma and without glaucoma using spectral-domain and time-domain OCT. Graefes Arch Clin Exp Ophthalmol. 2012 Feb;250(2):279-87. doi: 10.1007/s00417-011-1811-9. Epub 2011 Sep 10.
PubMed 21909812
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Nerve Fiber Layer Thickness Measurements in Patients With Glaucoma and Healthy Controls Using Spectral-Domain and Time-Domain OCT
- ClinicalTrials.gov ID
- NCT01273285
- Acronym / sponsor ID
- RNFL-Repro
- Conditions
- Glaucoma Patients and Healthy Controls
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- First posted
- 10 Jan 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 reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and to compare these results to conventional Time-Domain-OCT (TD-OCT).
- Trial with medical device
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18yo or older, healthy
- glaucom group: age 18yo or older, diagnosis of primary open angle glaucoma (POAG)
- Exclusion criteria: Exclusion criteria in the control group were history of glaucoma, history of any other ocular disease, or intraocular pressure greater than 21mmHg. Exclusion criteria in the glaucoma group were history of other optic neuropathies.
- or severe optic media opacities.
Key exclusion criteria (0 listed)
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, H | Device | – |
Primary outcome
reproducibility of retinal nerve fiber layer thickness measurement
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
- Derived from this study: PubMed 21909812Toteberg-Harms M, Sturm V, Knecht PB, Funk J, Menke MN. Repeatability of nerve fiber layer thickness measurements in patients with glaucoma and without glaucoma using spectral-domain and time-domain OCT. Graefes Arch Clin Exp Ophthalmol. 2012 Feb;250(2):279-87. doi: 10.1007/s00417-011-1811-9. Epub 2011 Sep 10.
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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spectralis® SD-OCT, Heidelberg Engineering GmbH, H in people with 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 4 inclusion and 0 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: stopped early, as of the sponsor's last update on 10 Jan 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
reproducibility of retinal nerve fiber layer thickness measurement. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01273285, which also lists 1 linked publication.
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 10 Jan 2011.