GlaucomaNCT00449631
Multidrug Resistance After Trabeculectomy With Mitomycin C
An observational study of Glaucoma and Trabeculectomy, run by University of Cologne at 1 site in Germany.
Trial summary
We investigate whether mitomycin C treatment during previous filtration surgery induces P-glycoprotein expression. Read more about this study
- Who is it for?
- Ages 8 to 85 years
- Conditions the study is for
- Glaucoma, Trabeculectomy
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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 8 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with planned trabeculectomy for elevated eye pressure
- one third of patients without previous trabeculectomy
- two thirds of patients with previous trabeculectomy (one third with and one third without the use of mitomycin C)
Who cannot join
- patients not requiring surgery
- patients with planned surgery for elevated eye pressure other than trabeculectomy
Trial locations and contacts
1 site in 1 country.
About this study
We investigate whether mitomycin C treatment during previous filtration surgery induces P-glycoprotein expression.
Read the detailed description
Despite the adjuvant use of mitomycin C during trabeculectomy, short-term and long-term failures still occur. We investigate whether mitomycin C treatment during previous trabeculectomy induces P-glycoprotein expression. Expression of P-glycoprotein is analysed in surgically removed Tenon tissue using immunohistochemistry.
- Conditions
- Glaucoma, Trabeculectomy
- Keywords
- Glaucoma, Drug Resistance, Multiple, Trabeculectomy
- Medical subject headings
- Glaucoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
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 GlaucomaStudies 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
- Time perspective
- Other
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Arno Hueber, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449631
- Sponsor's protocol ID
- Multidrug Resistance
- Status last verified
- Mar 2007
- First submitted
- 19 Mar 2007
- Last updated
- 26 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Hueber A, Esser JM, Kociok N, Welsandt G, Luke C, Roters S, Esser PJ. Mitomycin C induces multidrug resistance in glaucoma surgery. Graefes Arch Clin Exp Ophthalmol. 2008 Feb;246(2):297-304. doi: 10.1007/s00417-007-0695-1. Epub 2007 Oct 13.
PubMed 17934748
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidrug Resistance After Trabeculectomy With Mitomycin C
- ClinicalTrials.gov ID
- NCT00449631
- Acronym / sponsor ID
- Multidrug Resistance
- Conditions
- Glaucoma, Trabeculectomy
- Keywords
- Glaucoma, Drug Resistance, Multiple, Trabeculectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of CologneUniversity, hospital or other
- First posted
- 20 Mar 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.
We investigate whether mitomycin C treatment during previous filtration surgery induces P-glycoprotein expression.
Detailed description
Despite the adjuvant use of mitomycin C during trabeculectomy, short-term and long-term failures still occur. We investigate whether mitomycin C treatment during previous trabeculectomy induces P-glycoprotein expression. Expression of P-glycoprotein is analysed in surgically removed Tenon tissue using immunohistochemistry.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 8 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with planned trabeculectomy for elevated eye pressure
- one third of patients without previous trabeculectomy
- two thirds of patients with previous trabeculectomy (one third with and one third without the use of mitomycin C)
Key exclusion criteria (2 listed)
- patients not requiring surgery
- patients with planned surgery for elevated eye pressure other than trabeculectomy
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
Not reported in the source record.
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 26 Mar 2007.
- Derived from this study: PubMed 17934748Hueber A, Esser JM, Kociok N, Welsandt G, Luke C, Roters S, Esser PJ. Mitomycin C induces multidrug resistance in glaucoma surgery. Graefes Arch Clin Exp Ophthalmol. 2008 Feb;246(2):297-304. doi: 10.1007/s00417-007-0695-1. Epub 2007 Oct 13.
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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.
Arno Hueber, MD principal investigator
University of Cologne
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 and Trabeculectomy, run by University of Cologne 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 2 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 26 Mar 2007. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00449631, 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 26 Mar 2007.