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
About this trial
This is an interventional treatment trial for Cataract
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
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
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
Learn more about this trial
Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
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