NCT01384266已完成不适用
A Randomized, Multicenter, Masked Evaluation of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate for the Treatment of Inflammation Following Cataract Surgery
Associated Eye Care, Minnesota2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Intraocular inflammation grading
研究概览
简要总结
Patients are routinely given steroid eye drops following cataract surgery. This study will compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used following cataract surgery. Patients will be randomly assigned to one drop or the other, and evaluated for inflammation and intraocular pressure as part of the comparison. The study Doctor will be masked as to which drop the patient receives to avoid bias.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects age 18 and older undergoing routine cataract surgery.
排除标准
- •Subjects being treated for elevated intraocular pressure, retinopathy, maculopathy, cornea or vitreous opacities that would interfere with visual acuity.
- •Subjects with diabetes, pseudoexfoliation, uveitis, corneal endothelial disease, or active Herpes Simplex Virus(HSV) or Herpes Zoster Virus(HZV) Pupil Stretch and/or Limbal Relaxing Incision(LRIs) will be allowed.
- •Subjects with previous ocular trauma or intraocular surgery
- •Subjects with sensitivities to steroids.
- •Women who are not post-menopausal or are of child bearing potential will be excluded.
- •Intraoperative complications during surgery including posterior capsule rupture and vitreous loss
- •Subjects with best visual potential in the fellow eye worse than 20/60
- •Subjects who are expected to require concurrent ocular or systemic therapy with non-steroidal anti-inflammatory drugs (NSAIDS) mast cell stabilizers, antihistamines, or decongestants within 2 days prior to or during the 21 days following surgery. (Intraoperative NSAIDS for mydriasis are permitted.) 325 mg Aspirin is permitted.
- •Subjects who are expected to require concurrent ocular or systemic corticosteroids, immunosuppressants (including Restasis) within 14 days prior to or 21 days following surgery
结局指标
主要结局
Intraocular inflammation grading
时间窗: Day 21 Post-op
Slit Lamp examination will be done at each visit to grade intraocular inflammation
次要结局
- Intraocular pressure spikes(Day 21 post-op)
研究者
Stephen S. Lane, MD
Prinicipal Investigator
Associated Eye Care, Minnesota
研究点 (2)
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