search
Back to results

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

Primary Purpose

Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phacoemulsification, implantation of intraocular lens
Phacoemulsification, Implantation of IOL, trabeculotomy
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring glaucoma, cataract, surgery, intraocular pressure, phacoemulsification, trabeculotomy

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    June 29, 2006
    Last Updated
    July 22, 2010
    Sponsor
    Medical University of Vienna
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00346931
    Brief Title
    Phacotrabeculotomy Versus CCI+Phaco in Patients With Borderline Control of Intraocular Pressure
    Official Title
    Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2006
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    June 2007 (Actual)
    Study Completion Date
    June 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma
    Keywords
    glaucoma, cataract, surgery, intraocular pressure, phacoemulsification, trabeculotomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Phacoemulsification, implantation of intraocular lens
    Intervention Type
    Procedure
    Intervention Name(s)
    Phacoemulsification, Implantation of IOL, trabeculotomy
    Primary Outcome Measure Information:
    Title
    Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication
    Secondary Outcome Measure Information:
    Title
    Number of Patients with Constant Intraocular Pressure <18 mmHg without medication
    Title
    Number of Patients with Constant Intraocular Pressure <21 mmHg with/without medication
    Title
    Number of Patients needing surgical retreatment
    Title
    Number of Patients with failure of surgical retreatment
    Title
    Mean IOP after 1 and 2 years
    Title
    Mean number of medication after 1 and 2 years
    Title
    Number of intraoperative complications
    Title
    comparison of postoperative complications between the groups
    Title
    Visual acuity
    Title
    decrease in perimetry

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clemens Vass, Univ.Prof.Dr.med.univ.
    Organizational Affiliation
    Medical University of Vienna
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs