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Phacotrabeculotomy Versus CCI+Phaco in Patients With Borderline Control of Intraocular Pressure

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346931
First Posted: July 4, 2006
Last Update Posted: July 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose
The purpose of the study is to determine whether combined cataract and glaucoma surgery (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery alone in patients with borderline control of intraocular pressure.

Condition Intervention
Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma Procedure: Phacoemulsification, implantation of intraocular lens Procedure: Phacoemulsification, Implantation of IOL, trabeculotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication

Secondary Outcome Measures:
  • Number of Patients with Constant Intraocular Pressure <18 mmHg without medication
  • Number of Patients with Constant Intraocular Pressure <21 mmHg with/without medication
  • Number of Patients needing surgical retreatment
  • Number of Patients with failure of surgical retreatment
  • Mean IOP after 1 and 2 years
  • Mean number of medication after 1 and 2 years
  • Number of intraoperative complications
  • comparison of postoperative complications between the groups
  • Visual acuity
  • decrease in perimetry

Enrollment: 9
Study Start Date: December 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical Diagnosis of Primary Open Angle or Pseudoexfoliative Glaucoma and Cataract

Exclusion Criteria:

  • Other glaucoma than POAG or PEX-Glaucoma
  • Medically uncontrolled Glaucoma:

IOP > 24 mmHg with two topical medications IOP > 21 mmHg with three topical medications

  • IOP < 18 mmHg with two topical medications IOP < 16 mmHg with three topical medications
  • previous ocular surgery
  • other ocular pathologies affecting visual acuity
  • disorders of immune system
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346931


Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Clemens Vass, Univ.Prof.Dr.med.univ. Medical University of Vienna
  More Information

Responsible Party: Prof. Dr. Clemens Vass, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00346931     History of Changes
Other Study ID Numbers: CCI-PTO-2004-AKH
First Submitted: June 29, 2006
First Posted: July 4, 2006
Last Update Posted: July 23, 2010
Last Verified: June 2006

Keywords provided by Medical University of Vienna:
glaucoma
cataract
surgery
intraocular pressure
phacoemulsification
trabeculotomy

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases