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Influence of Trabeculectomy and Phaco-trabeculectomy on Corneal Astigmatism

Primary Purpose

Astigmatism, Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biometry
Refraction
Corneal Topography
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Trabeculectomy or Phaco-Trabeculectomy between 01/2017 and 12/2017
  • Age ≥18 years

Exclusion Criteria:

  • Acute or chronic corneal diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    All Eyes

    Arm Description

    All eyes undergo the same interventions. These are the following examinations: Biometry, Refraction and Corneal Topography. The examinations take place 6 months after surgery

    Outcomes

    Primary Outcome Measures

    Difference in Astigmatism [Diopters (dpt)]

    Secondary Outcome Measures

    Full Information

    First Posted
    October 20, 2016
    Last Updated
    October 26, 2016
    Sponsor
    University of Zurich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02945202
    Brief Title
    Influence of Trabeculectomy and Phaco-trabeculectomy on Corneal Astigmatism
    Official Title
    Einfluss Der Trabekulektomie Und Der Kombinierten Phako-Trabekulektomie Auf Den Kornealen Astigmatismus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    February 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Zurich

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study investigates the effects of trabeculectomy and combined phacoemulsification plus trabeculectomy on corneal astigmatism.
    Detailed Description
    Prospectively, consecutive patients at the University Hospital of Zurich undergoing either trabeculectomy (trab) or phaco-trabeculectomy (phaco-trab) are included in this study between January and December 2017. The study interventions takes place 6 months after surgery and include examination of refraction, biometry and corneal topography in order to assess the patient's astigmatism. The values are compared to the preoperative baseline values, which are available from patient records.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Astigmatism, Glaucoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    All Eyes
    Arm Type
    Other
    Arm Description
    All eyes undergo the same interventions. These are the following examinations: Biometry, Refraction and Corneal Topography. The examinations take place 6 months after surgery
    Intervention Type
    Device
    Intervention Name(s)
    Biometry
    Intervention Description
    All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery
    Intervention Type
    Device
    Intervention Name(s)
    Refraction
    Intervention Description
    All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery
    Intervention Type
    Device
    Intervention Name(s)
    Corneal Topography
    Intervention Description
    All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery
    Primary Outcome Measure Information:
    Title
    Difference in Astigmatism [Diopters (dpt)]
    Time Frame
    preoperative astigmatism compared to 6 months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Trabeculectomy or Phaco-Trabeculectomy between 01/2017 and 12/2017 Age ≥18 years Exclusion Criteria: Acute or chronic corneal diseases

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Influence of Trabeculectomy and Phaco-trabeculectomy on Corneal Astigmatism

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