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

This study has been terminated.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00346931
First received: June 29, 2006
Last updated: July 22, 2010
Last verified: June 2006
History of Changes

June 29, 2006
July 22, 2010
December 2004
June 2007   (final data collection date for primary outcome measure)
Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication
Same as current
Complete list of historical versions of study NCT00346931 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Phacotrabeculotomy Versus CCI+Phaco in Patients With Borderline Control of Intraocular Pressure
Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Open Angle Glaucoma
  • Pseudoexfoliative Glaucoma
  • Procedure: Phacoemulsification, implantation of intraocular lens
  • Procedure: Phacoemulsification, Implantation of IOL, trabeculotomy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00346931
CCI-PTO-2004-AKH
Not Provided
Prof. Dr. Clemens Vass, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Clemens Vass, Univ.Prof.Dr.med.univ. Medical University of Vienna
Medical University of Vienna
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP