UveitisNCT00917670
Ultrastructural Changes of Trabeculectomy Specimens in Patients With Uveitic Secondary Glaucoma
An observational study of Uveitis and Secondary Glaucoma, run by St. Franziskus Hospital at 1 site in Germany.
Trial summary
Ultrastructural analysis of trabeculectomy specimens of patients with uveitic secondary glaucoma. To evaluate morphological changes and to compare to primary open angle glaucoma patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uveitis, Secondary Glaucoma
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with uveitic secondary glaucoma in need of surgical intervention.
Who may be able to join
- secondary uveitic glaucoma
- IOP > 24 mmhg with topical and/or systemic therapy
- need for surgical intervention to control IOP
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anatomy II at University of Erlangen, Germany
Erlangen
About this study
Ultrastructural analysis of trabeculectomy specimens of patients with uveitic secondary glaucoma.
To evaluate morphological changes and to compare to primary open angle glaucoma patients.
- Conditions
- Uveitis, Secondary Glaucoma
- Keywords
- trabecular meshwork, electron microscopy
- Medical subject headings
- Uveitis
What is being measured
The primary outcome is the main question the study is designed to answer.
morphological changes
Measured: after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionDec 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Franziskus Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917670
- Sponsor's protocol ID
- 2009-200-f-S-
- Status last verified
- Jul 2010
- First submitted
- 9 Jun 2009
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrastructural Changes of Trabeculectomy Specimens in Patients With Uveitic Secondary Glaucoma
- ClinicalTrials.gov ID
- NCT00917670
- Acronym / sponsor ID
- 2009-200-f-S-
- Conditions
- Uveitis, Secondary Glaucoma
- Keywords
- trabecular meshwork, electron microscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- St. Franziskus HospitalUniversity, hospital or other
- Collaborators
- University of Erlangen-Nürnberg Medical School
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Jun 2009 (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.
Ultrastructural analysis of trabeculectomy specimens of patients with uveitic secondary glaucoma.
To evaluate morphological changes and to compare to primary open angle glaucoma patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with uveitic secondary glaucoma in need of surgical intervention.
Key inclusion criteria (3 listed)
- secondary uveitic glaucoma
- IOP > 24 mmhg with topical and/or systemic therapy
- need for surgical intervention to control IOP
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.
Primary outcome
morphological changes
Time frame: after surgery
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 22 Jul 2010.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Secondary 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 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: finished, as of the sponsor's last update on 22 Jul 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 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?
morphological changes (time frame: after surgery). 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 22 Jul 2010.