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Comparing Eye Pressure Using Maximal Tolerated Local Therapy or Systemic Acetazolamide

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01274039
First received: January 10, 2011
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Control of Elevated Eye Pressure by Local and Systemic Therapy
 Drug: Acetazolamide for glaucoma patients to lower eye pressure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparing Eye Pressure Using Maximal Tolerated Local Therapy or Systemic Acetazolamide. A Possible Pretreatment for Trabeculectomy Surgery.

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Eye pressure [ Time Frame: Once at the beginning of the study and once 3 to 4 weeks later ] [ Designated as safety issue: No ]
    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.


Study Start Date: February 2009
Study Completion Date: February 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient with a trabeculectomy planed Drug: Acetazolamide for glaucoma patients to lower eye pressure
Acetazolamide tablets 3 times daily for 3 to 4 weeks

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients of the university hospital with a planed trabeculectomy in 3 to 4 weeks.

Criteria

Inclusion Criteria:

  • Patients with uncontrolled intraocular eye pressure
  • Patients with planed trabeculectomy in 3 to 4 weeks

Exclusion Criteria:

  • Patients not meeting the inclusion criteria
  • Patients with known intolerance to acetazolamide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274039

Locations
Germany
University of Cologne
Cologne, Germany, 50924
Sponsors and Collaborators
University of Cologne
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01274039     History of Changes
Other Study ID Numbers: AcetazolamideTrialCologne
Study First Received: January 10, 2011
Last Updated: April 12, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Acetazolamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013