Dextenza in Pterygium Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient satisfaction-comfort and convenience
研究概览
简要总结
DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of pterygium with conjunctival autograft)
详细描述
In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA or topical prednisolone acetate 1%.15 eyes will receive a Dextenza insertion into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued. 15 eyes will receive starting on postoperative day 1 topical prednisolone acetate 1% q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- •Age of at least 18 years with primary pterygia
排除标准
- •A patient who meets any of the following criteria will be excluded from the study:
- •Ocular hypertension
- •Prior conjunctival surgery
- •Other uncontrolled ocular disease
- •Ocular surgery in either eye within 3 months
- •Use of eye drops other than postoperative medications and artificial tears
研究组 & 干预措施
DEXTENZA Group
Patients with Pterygium DEXTENZA Group
干预措施: Dexamethasone Intracanalicular Insert, 0.4mg (Drug)
Topical Prednisolone Acetate 1% Group
Patients with Pterygium Topical Prednisolone Acetate 1% Group
干预措施: Prednisolone Acetate 1% (Drug)
结局指标
主要结局
Patient satisfaction-comfort and convenience
时间窗: Assessed on Month 6
Assessed by patient reported questionnaire
次要结局
- To compare the degree of conjunctival hyperemia(Assessed on Month 6)
- Mean number of days for corneal re-epithelialization(Assessed on Month 1)
- Recurrence of pterygium(Assessed at Month 6)
研究者
Michelle Rhee MD
Principal Investigator
New York Eye Specialists