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This randomized controlled trial compares two regimens of topical therapy:
Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are evaluated for
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobramycin/Dexamethasone | Active Comparator |
| |
| Tobramycin/Dexamethasone plus Ketorolac tromethamine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Tobramycin 0.3% - Dexamethasone 0.1% | Drug | one drop four times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity, corneal edema, Tyndall reaction, redness | 1,7,14,28 post-operative day, Up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonidas E Papazisis, Director | leopapazisis@yahoo.gr | Study Director |
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|
| Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine | Drug | Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day |
|
|
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014031 | Tobramycin |
| D000078162 | Tobramycin, Dexamethasone Drug Combination |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003907 | Dexamethasone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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