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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure

Resource links provided by NLM:

MedlinePlus related topics: Cataract Glaucoma
U.S. FDA Resources

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346931

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

No publications provided

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
Study First Received: June 29, 2006
Last Updated: July 22, 2010
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on May 23, 2013