Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 主要终点
- Visual acuity, corneal edema, Tyndall reaction, redness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •phacoemulsification (due to cataract)
- •uneventful phacoemulsification surgery
排除标准
- •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
研究组 & 干预措施
Tobramycin/Dexamethasone
干预措施: Drug: Tobramycin 0.3% - Dexamethasone 0.1% (Drug)
Tobramycin/Dexamethasone
干预措施: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine (Drug)
Tobramycin/Dexamethasone plus Ketorolac tromethamine
干预措施: Drug: Tobramycin 0.3% - Dexamethasone 0.1% (Drug)
Tobramycin/Dexamethasone plus Ketorolac tromethamine
干预措施: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine (Drug)
结局指标
主要结局
Visual acuity, corneal edema, Tyndall reaction, redness
时间窗: 1,7,14,28 post-operative day, Up to 28 days
次要结局
未报告次要终点