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

NCT ID: NCT00346931

Last Updated: 2010-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Phacoemulsification, implantation of intraocular lens

Intervention Type PROCEDURE

Phacoemulsification, Implantation of IOL, trabeculotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Other Identifiers

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CCI-PTO-2004-AKH

Identifier Type: -

Identifier Source: org_study_id

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