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

This study is currently recruiting participants.

Verified by Medical University of Vienna, June 2006

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00346931

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

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure

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

Estimated Enrollment:	150
Study Start Date:	December 2004

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

Contacts

Contact: Clemens Vass, Univ.-Prof. Dr. med. univ.	+43 1 40400 ext 7940	clemens.vass@meduniwin.ac.at
Contact: Cornelia Hirn, Dr. med. univ.	+43 1 40400 ext 7940	cornelia.hirn@meduniwien.ac.at

Locations

Austria
Hanusch-Krankenhaus	Recruiting
Vienna, Austria, 1140
Contact: Karl Rigal, Dr.med.univ. +43 1 91021 ext 84620 karl.rigal@wgkk.sozvers.at
Principal Investigator: Karl Rigal, Dr.med.univ.

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Clemens Vass, Univ.Prof.Dr.med.univ.

Medical University of Vienna

More Information

Study ID Numbers:	CCI-PTO-2004-AKH
Study First Received:	June 29, 2006
Last Updated:	October 12, 2006
ClinicalTrials.gov Identifier:	NCT00346931
Health Authority:	Austria: Ethikkommission

Keywords provided by Medical University of Vienna:

glaucoma
cataract
surgery

intraocular pressure
phacoemulsification
trabeculotomy

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Cataract

Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 14, 2009