A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal Transplant or Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Mean change in pain score
研究概览
简要总结
A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal transplant or Cataract surgery
详细描述
A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert, placed within the lower or upper eye lid canaliculus in conjunction with topical steroid Prior to or Following Corneal transplant or Cataract surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Patients who received DEXTENZA insertion perioperatively.
排除标准
- •Any patient who did not receive DEXTENZA insertion
研究组 & 干预措施
Dextenza recepient
A Retrospective Review DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal Transplant or Cataract Surgery
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
结局指标
主要结局
Mean change in pain score
时间窗: Assessed for 3 months after drug insertion
As measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worse pain possible
Mean change in inflammation (Cell and Flare) scores
时间窗: Assessed for 3 months after drug insertion
As measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1
次要结局
- Change in BCVA(Assessed for 3 months after drug insertion)
- Resolution of pain(Assessed for 1 months after drug insertion)
- Resolution of anterior chamber inflammation(Assessed for 3 months after drug insertion)
- Proportion of eyes requiring additional post-operative therapy(Assessed for 3 months after drug insertion)
- Number of patient call-backs regarding post-operative pain(Assessed for 3 months after drug insertion)
- Number of pharmacy call-backs regarding post-operative medication(Assessed for 3 months after drug insertion)
- Adverse events(Assessed for 3 months after drug insertion)
- Mean change in IOP(Assessed for 3 months after drug insertion)
研究者
Nicole Fram M.D.
Principal Investigator
Advanced Vision Care