Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
- Conditions
- Cataract
- Registration Number
- NCT01103401
- Lead Sponsor
- Veroia General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- phacoemulsification (due to cataract)
- uneventful phacoemulsification surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual acuity, corneal edema, Tyndall reaction, redness 1,7,14,28 post-operative day, Up to 28 days
- Secondary Outcome Measures
Name Time Method