GlaucomaNCT01115218
The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy
An observational study of Glaucoma and Trabeculectomy, run by University of Cologne at 1 site in Germany.
Trial summary
The aim of the study is to investigate whether it is possible to predict the success of trabeculectomy in patients with glaucoma through the examination of mediators of wound healing in anterior chamber fluid. The success rate of trabeculectomy with mitomycin C in the literature is about 75%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Trabeculectomy, Wound Healing
- What is being tested?
- Trabeculectomy
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Mar 2012
- 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: Patients from the University Eye Hospital of Cologne
Who may be able to join
- patients with glaucoma with a trabeculectomy required
- 60 eyes of 60 patients, The ratio of female / male is not involved.
- Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).
- age of at least 18 years
Who cannot join
- all patients not included in the group of inclusion criteria.
- less than 50yl anterior chamber fluid could be collected during the operation.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Eye Hospital, University of Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
The aim of the study is to investigate whether it is possible to predict the success of trabeculectomy in patients with glaucoma through the examination of mediators of wound healing in anterior chamber fluid. The success rate of trabeculectomy with mitomycin C in the literature is about 75%. This leads on the question why 25% of the patients received trabeculectomy are not sufficient treated and have not a long-term IOP reduction. Precisely this question is to be examined by the study.
- Conditions
- Glaucoma, Trabeculectomy, Wound Healing
- Being tested
- Trabeculectomy
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabeculectomyProcedure or surgery
Trabeculectomy with mitomycin C
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma patients | Not described Receives: Procedure: Trabeculectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arno Hueber, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115218
- Sponsor's protocol ID
- MeVeTra-2009
- Status last verified
- Nov 2018
- First submitted
- 3 May 2010
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy
- ClinicalTrials.gov ID
- NCT01115218
- Acronym / sponsor ID
- MeVeTra-2009
- Conditions
- Glaucoma, Trabeculectomy, Wound Healing
- Keywords
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 May 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.
The aim of the study is to investigate whether it is possible to predict the success of trabeculectomy in patients with glaucoma through the examination of mediators of wound healing in anterior chamber fluid. The success rate of trabeculectomy with mitomycin C in the literature is about 75%. This leads on the question why 25% of the patients received trabeculectomy are not sufficient treated and have not a long-term IOP reduction. Precisely this question is to be examined by the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma patients | – | Procedure: Trabeculectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the University Eye Hospital of Cologne
Key inclusion criteria (4 listed)
- patients with glaucoma with a trabeculectomy required
- 60 eyes of 60 patients, The ratio of female / male is not involved.
- Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).
- age of at least 18 years
Key exclusion criteria (2 listed)
- all patients not included in the group of inclusion criteria.
- less than 50yl anterior chamber fluid could be collected during the operation.
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 |
|---|---|---|
| TrabeculectomyTrabeculectomy with mitomycin C | Procedure or surgery | Glaucoma patients |
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 20 Nov 2018.
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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 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 4 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 20 Nov 2018. 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?
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 20 Nov 2018.