Control of Elevated Eye Pressure by Local and Systemic TherapyNCT01274039
Comparing Eye Pressure Using Maximal Tolerated Local Therapy or Systemic Acetazolamide
An observational study of Control of Elevated Eye Pressure by Local and Systemic Therapy, run by University of Cologne at 1 site in Germany.
Trial summary
Local therapy for glaucoma is known to induce a conjunctival inflammation. Because of this, trabeculectomy is more likely to fail. The investigators exchange the local therapy by systemic therapy using acetazolamide and measure the eye pressure using local therapy and systemic therapy using acetazolamide. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Control of Elevated Eye Pressure by Local and Systemic Therapy
- What is being tested?
- Acetazolamide for glaucoma patients to lower eye pressure
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients of the university hospital with a planed trabeculectomy in 3 to 4 weeks.
Who may be able to join
- Patients with uncontrolled intraocular eye pressure
- Patients with planed trabeculectomy in 3 to 4 weeks
Who cannot join
- Patients not meeting the inclusion criteria
- Patients with known intolerance to acetazolamide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Eye Pressure Using Maximal Tolerated Local Therapy or Systemic Acetazolamide. A Possible Pretreatment for Trabeculectomy Surgery.
Local therapy for glaucoma is known to induce a conjunctival inflammation. Because of this, trabeculectomy is more likely to fail. The investigators exchange the local therapy by systemic therapy using acetazolamide and measure the eye pressure using local therapy and systemic therapy using acetazolamide. The investigators suspect an elevated eye pressure using acetazolamide compared to local therapy. In summary acetazolamide could be a better choice in reference to conjunctival inflammation, but a worse choice in reference to controlling eye pressure.
- Being tested
- Acetazolamide for glaucoma patients to lower eye pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetazolamide for glaucoma patients to lower eye pressureDrug
Acetazolamide tablets 3 times daily for 3 to 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patient with a trabeculectomy planed | Not described Receives: Drug: Acetazolamide for glaucoma patients to lower eye pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye pressure
The eye pressure is measured at the beginning of the study, when the patient is using the maximal tolerated local therapy and 3 to 4 weeks later, when using systemic acetazolamide treatment.
Measured: Once at the beginning of the study and once 3 to 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Control of Elevated Eye Pressure by Local and Systemic TherapyStudies 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
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274039
- Sponsor's protocol ID
- AcetazolamideTrialCologne
- Status last verified
- Apr 2013
- First submitted
- 10 Jan 2011
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Eye Pressure Using Maximal Tolerated Local Therapy or Systemic Acetazolamide. A Possible Pretreatment for Trabeculectomy Surgery.
- ClinicalTrials.gov ID
- NCT01274039
- Acronym / sponsor ID
- AcetazolamideTrialCologne
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Jan 2011 (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.
Local therapy for glaucoma is known to induce a conjunctival inflammation. Because of this, trabeculectomy is more likely to fail. The investigators exchange the local therapy by systemic therapy using acetazolamide and measure the eye pressure using local therapy and systemic therapy using acetazolamide. The investigators suspect an elevated eye pressure using acetazolamide compared to local therapy. In summary acetazolamide could be a better choice in reference to conjunctival inflammation, but a worse choice in reference to controlling eye pressure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with a trabeculectomy planed | – | Drug: Acetazolamide for glaucoma patients to lower eye pressure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients of the university hospital with a planed trabeculectomy in 3 to 4 weeks.
Key inclusion criteria (2 listed)
- Patients with uncontrolled intraocular eye pressure
- Patients with planed trabeculectomy in 3 to 4 weeks
Key exclusion criteria (2 listed)
- Patients not meeting the inclusion criteria
- Patients with known intolerance to acetazolamide
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 |
|---|---|---|
| Acetazolamide for glaucoma patients to lower eye pressureAcetazolamide tablets 3 times daily for 3 to 4 weeks | Drug | Patient with a trabeculectomy planed |
Primary outcome
Eye pressure
Time frame: Once at the beginning of the study and once 3 to 4 weeks later
The eye pressure is measured at the beginning of the study, when the patient is using the maximal tolerated local therapy and 3 to 4 weeks later, when using systemic acetazolamide treatment.
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 15 Apr 2013.
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 Control of Elevated Eye Pressure by Local and Systemic Therapy, 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 2 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 15 Apr 2013. 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?
Eye pressure (time frame: Once at the beginning of the study and once 3 to 4 weeks later). 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 15 Apr 2013.