Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery
NCT00992355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97
Last updated 2009-10-09
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. The topical treatment is administered for 28 days after phacoemulsification.
Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for
* corneal edema
* conjunctival redness
* anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.
Conditions
- Cataract
Interventions
- DRUG
-
Tobramycin 0.3% - Dexamethasone 0.1%
- DRUG
-
Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%
Sponsors & Collaborators
-
Veroia General Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Max Age
- 95 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2009-03-31
- Completion
- 2009-04-30
Countries
- Greece
Study Locations
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