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Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Drug: Tobramycin 0.3% - Dexamethasone 0.1%
Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
Sponsored by
Veroia General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

55 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • phacoemulsification (due to cataract)
  • uneventful phacoemulsification surgery

Exclusion Criteria:

  • history of intraocular surgery in the operated eye,
  • any previous episode of uveitis in the operated eye,
  • severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy),
  • regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months
  • disruption of the anterior lens capsule

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Tobramycin/Dexamethasone

    Tobramycin/Dexamethasone plus Ketorolac tromethamine

    Arm Description

    Outcomes

    Primary Outcome Measures

    Visual acuity, corneal edema, Tyndall reaction, redness

    Secondary Outcome Measures

    Full Information

    First Posted
    April 13, 2010
    Last Updated
    April 14, 2015
    Sponsor
    Veroia General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01103401
    Brief Title
    Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
    Official Title
    Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Veroia General Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This randomized controlled trial compares two regimens of topical therapy: tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are evaluated for corneal edema conjunctival hyperemia anterior chamber (Tyndall) reaction. The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist.
    Detailed Description
    Patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (TD group, n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid, plus Ketorolac tromethamine 0.5%, one drop tid (TD-K group, n=73, 28 days). Patients undergoing vitrectomy due to posterior capsule rupture were excluded. On days 7, 14, 21, 28, the frequency of inflammation-related signs [corneal edema, conjunctival hyperemia, anterior chamber (Tyndall) reaction], as well as the best corrected visual acuity (BCVA) were measured. On day 21, logistic regression was performed to evaluate risk factors for inflammation.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    145 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tobramycin/Dexamethasone
    Arm Type
    Active Comparator
    Arm Title
    Tobramycin/Dexamethasone plus Ketorolac tromethamine
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Drug: Tobramycin 0.3% - Dexamethasone 0.1%
    Other Intervention Name(s)
    Tobradex
    Intervention Description
    one drop four times per day
    Intervention Type
    Drug
    Intervention Name(s)
    Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
    Other Intervention Name(s)
    Acular
    Intervention Description
    Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day
    Primary Outcome Measure Information:
    Title
    Visual acuity, corneal edema, Tyndall reaction, redness
    Time Frame
    1,7,14,28 post-operative day, Up to 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: phacoemulsification (due to cataract) uneventful phacoemulsification surgery Exclusion Criteria: history of intraocular surgery in the operated eye, any previous episode of uveitis in the operated eye, severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy), regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months disruption of the anterior lens capsule
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leonidas E Papazisis, Director
    Organizational Affiliation
    leopapazisis@yahoo.gr
    Official's Role
    Study Director

    12. IPD Sharing Statement

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