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

Overview

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.

Full Title of Study: “Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 2010

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.

Interventions

  • Drug: Drug: Tobramycin 0.3% – Dexamethasone 0.1%
    • one drop four times per day
  • Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
    • Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day

Arms, Groups and Cohorts

  • Active Comparator: Tobramycin/Dexamethasone
  • Active Comparator: Tobramycin/Dexamethasone plus Ketorolac tromethamine

Clinical Trial Outcome Measures

Primary Measures

  • Visual acuity, corneal edema, Tyndall reaction, redness
    • Time Frame: 1,7,14,28 post-operative day, Up to 28 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Veroia General Hospital
  • Provider of Information About this Clinical Study
    • Department of Ophthalmology, Veroia General Hospital
  • Overall Official(s)
    • Leonidas E Papazisis, Director, Study Director, leopapazisis@yahoo.gr

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