UveitisNCT01170481
Assessment of Retinal Nerve Fibre Layer by Optical Coherence Tomography in Uveitis Patients With Papilloedema
An observational study of Uveitis and Glaucoma, run by St. Franziskus Hospital at 1 site in Germany.
Trial summary
Assessment of optic disc morphology can be difficult in patients with uveitis and papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning techniques may help to detect damage to the retinal nerve fibre layer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Apr 2011
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with anterior or intermediate uveitis and papillooedema in fluoreszein angiography.
Who may be able to join
- anterior or intermediate uveitis
- papilloedema
- glaucoma
Who cannot join
- dense cataract
- dense vitreous opacification
- circular posterior synechiae
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Ophthalmology at St.-Franziskus Hospital
Münster, 48145
About this study
Official title: Retinal Nerve Fibre Layer in Uveitic Secondary Glaucoma
Assessment of optic disc morphology can be difficult in patients with uveitis and papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning techniques may help to detect damage to the retinal nerve fibre layer.
- Keywords
- anterior and intermediate uveitis, papilloedema
- Medical subject headings
- Uveitis, Glaucoma, Uveitis, Intermediate, Papilledema
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 |
|---|---|---|
| papilloedema without glaucoma | Not described | |
| papilloedema with glaucoma | Not described | |
| glaucoma without papilloedema | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations of retinal nerve fibre layer by optical coherence tomography
Baseline comparision of retinal nerve fibre layer thickness in patients with uveitis and with or without papilloedema at study entry. No follow-up examination scheduled
Measured: once at study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionApr 2011
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 UveitisStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Franziskus Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Heinz, St. Franziskus Hospital
- Investigators
- Arnd Heiligenhaus, MD, Study chair, Department at St. Franziskus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170481
- Sponsor's protocol ID
- 2008-128-f-S
- Status last verified
- Nov 2015
- First submitted
- 21 Jul 2010
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heinz C, Kogelboom K, Heiligenhaus A. Influence of optic disc leakage on objective optic nerve head assessment in patients with uveitis. Graefes Arch Clin Exp Ophthalmol. 2016 Feb;254(2):361-4. doi: 10.1007/s00417-015-3218-5. Epub 2015 Nov 18.
PubMed 26582161
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Nerve Fibre Layer in Uveitic Secondary Glaucoma
- ClinicalTrials.gov ID
- NCT01170481
- Acronym / sponsor ID
- 2008-128-f-S
- Keywords
- anterior and intermediate uveitis, papilloedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Franziskus HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Jul 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.
Assessment of optic disc morphology can be difficult in patients with uveitis and papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning techniques may help to detect damage to the retinal nerve fibre layer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| papilloedema without glaucoma | – | – |
| papilloedema with glaucoma | – | – |
| glaucoma without papilloedema | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with anterior or intermediate uveitis and papillooedema in fluoreszein angiography.
Key inclusion criteria (3 listed)
- anterior or intermediate uveitis
- papilloedema
- glaucoma
Key exclusion criteria (3 listed)
- dense cataract
- dense vitreous opacification
- circular posterior synechiae
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
Alterations of retinal nerve fibre layer by optical coherence tomography
Time frame: once at study entry
Baseline comparision of retinal nerve fibre layer thickness in patients with uveitis and with or without papilloedema at study entry. No follow-up examination scheduled
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 18 Nov 2015.
- Derived from this study: PubMed 26582161Heinz C, Kogelboom K, Heiligenhaus A. Influence of optic disc leakage on objective optic nerve head assessment in patients with uveitis. Graefes Arch Clin Exp Ophthalmol. 2016 Feb;254(2):361-4. doi: 10.1007/s00417-015-3218-5. Epub 2015 Nov 18.
- Related InfoLink provided by the sponsor.
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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.
Arnd Heiligenhaus, MD study chair
Department at St. Franziskus Hospital
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 Uveitis and Glaucoma, run by St. Franziskus Hospital at 1 site in Germany.
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 3 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 18 Nov 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 Germany. 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.
What does the primary outcome measure?
Alterations of retinal nerve fibre layer by optical coherence tomography (time frame: once at study entry). 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 NCT01170481, 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 18 Nov 2015.