UveitisNCT00552019
Intraocular Pressure (IOP) Assessed by Dynamic Contour Tonometer (DCT) and Goldman Applanation Tonometry (GAT)
An observational study of Uveitis and Intraocular Pressure, run by St. Franziskus Hospital at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate an assessment of the intraocular pressure with the dynamic contour tonometry and the Goldmann applanation tonometry in patients with active anterior uveitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Intraocular Pressure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Apr 2009
- 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
- No healthy volunteers
- Adult, Older adult
Study population: tertiary referral center
Who may be able to join
- active anterior or panuveitis with keratoprecipitates
Who cannot join
- corneal endothelial dystrophy
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: Inflammatory Changes of Corneal Thickness and Influence on Assessment of Intraocular Pressure
The purpose of this study is to evaluate an assessment of the intraocular pressure with the dynamic contour tonometry and the Goldmann applanation tonometry in patients with active anterior uveitis.
Read the detailed description
Keratoprecipitates are often found in anterior uveitis. Also elevation of the IOP can be seen in these patients. Goldmann applanation tonometry is the standard technique to assess the IOP but depends on the corneal thickness. Therefore IOP is measured by Goldmann and dynamic contour tonometry and corneal thickness is quantified by Orbscan at active uveitis and after the keratoprecipitates have disappeared.
- Conditions
- Uveitis, Intraocular Pressure
- Medical subject headings
- Uveitis
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP by GAT and DCT
Measured: 3 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Franziskus Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Arnd Heiligenhaus, MD, Study director, Department of Ophthalmology at St.-Franziskus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552019
- Sponsor's protocol ID
- 2007-405-f-S
- Status last verified
- Nov 2009
- First submitted
- 31 Oct 2007
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Changes of Corneal Thickness and Influence on Assessment of Intraocular Pressure
- ClinicalTrials.gov ID
- NCT00552019
- Acronym / sponsor ID
- 2007-405-f-S
- Conditions
- Uveitis, Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Franziskus HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 1 Nov 2007 (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 an assessment of the intraocular pressure with the dynamic contour tonometry and the Goldmann applanation tonometry in patients with active anterior uveitis.
Detailed description
Keratoprecipitates are often found in anterior uveitis. Also elevation of the IOP can be seen in these patients. Goldmann applanation tonometry is the standard technique to assess the IOP but depends on the corneal thickness. Therefore IOP is measured by Goldmann and dynamic contour tonometry and corneal thickness is quantified by Orbscan at active uveitis and after the keratoprecipitates have disappeared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary referral center
Key inclusion criteria (1 listed)
- active anterior or panuveitis with keratoprecipitates
Key exclusion criteria (1 listed)
- corneal endothelial dystrophy
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
IOP by GAT and DCT
Time frame: 3 months after treatment start
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 2009.
- 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 director
Department of Ophthalmology 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 Intraocular Pressure, 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 1 inclusion and 1 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 2009. 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?
IOP by GAT and DCT (time frame: 3 months after treatment start). 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 18 Nov 2009.