Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Prevention Of Retinal Thickening
研究概览
简要总结
The purpose of this study is to determine if Lotemax eye drops are at least as effective as Pred Forte eye drops, which are the standard of care after cataract surgery.
详细描述
Prednisolone 1%, a topical steroid, is considered standard of care following cataract surgery to reduce inflammation. We aim to determine if Lotemax is at least as effective as Prednisolone. If so, these findings would demonstrate that physicians have other treatment options to consider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •Male or female >18 years of age scheduled to undergo cataract surgery
- •Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
- •Expected visual outcome of BCVA (best corrected visual acuity)> 20/25 postoperatively, as determined by potential visual acuity testing and review of preoperative corneal topography and OCT (optical coherence tomography).
- •Ability to provide informed consent, take study medications as directed, and likely to complete all study visits
排除标准
- •Known contraindication to any study medication or any of their components
- •Required use of ocular medications other than the study medications during the study
- •Evidence of macular disease (Epiretinal membrane, Vitreomacular traction syndrome, macular hole) on preoperative OCT (optical coherence tomography)
- •Presence of significant dry macular degeneration that may impact postoperative visual results.
- •History of retinal vein occlusion or diabetic macular edema, uveitis or any macular disease predisposing them to cystoid macular edema or prolonged intraocular inflammation.
- •Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
- •Anticipated need for mechanical iris dilating devices
- •Presence of Epithelial Basement Membrane Dystrophy, significant dry eye, significant blepharitis, or any other corneal condition that may impact BCVA (best corrected visual acuity) postoperatively
研究组 & 干预措施
Pred Forte
Patients scheduled to undergo phacoemulsification will be randomized in a 1:1 schedule to receive Pred Forte BID for 4 weeks postop. All patients will receive Xibrom BID for one month and Besifloxacin BID for 7 to 10 days postop.
干预措施: Pred Forte (Drug)
Lotemax
patients scheduled to undergo phacoemulsification will be randomized in a 1:1 schedule to receive Lotemax BID for 4 weeks postop. All patients will receive Xibrom BID for one month and Besifloxacin BID for 7 to 10 days postop.
干预措施: Lotemax (Drug)
结局指标
主要结局
Prevention Of Retinal Thickening
时间窗: 1 Year
* OCT (optical coherence tomography) with macular thickening * Incidence of CME ( cystoids macular edema) * BCVA (best corrected visual acuity) * UCVA (uncorrected visual acuity) * Central corneal thickness
次要结局
未报告次要终点