Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Mean change in pain score
研究概览
简要总结
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.
详细描述
Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Pseudophakic
- •Retinal Detachment
- •Age 18 years and older
- •Scheduled for gas bubble repair and laser surgery following retinal detachment
- •Willing and able to comply with clinic visits and study related procedures
- •Willing and able to sign the informed consent form
排除标准
- •Patients under the age of
- •Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- •Active infectious systemic disease
- •Active infectious ocular or extraocular disease
- •Obstructed nasolacrimal duct in the study eye(s)
- •Hypersensitivity to dexamethasone
- •Patients being treated with immunomodulating agents in the study eye(s)
- •Patients being treated with immunosuppressants and/or oral steroids
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
研究组 & 干预措施
Intracanalicular Sustained Release Dexamethasone, 0.4 mg
Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery.
干预措施: Dextenza (Drug)
topical prednisolone acetate 1%.
干预措施: Prednisolone Acetate (Drug)
结局指标
主要结局
Mean change in pain score
时间窗: 30 Days
Average change in pain based on whats reported on the Ocular Pain Assessment
Post-op pain scores
时间窗: 30 Days
Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.
次要结局
- Best Corrected Visual Acuity(90 days)
- Physician Ease of Dextenza insertion(Day 1)
- Mean change in anterior chamber cell and flare score(30 days)
- Cystoid Macular Edema(30 days)
研究者
Neil Finnen, MD
Principal Investigator
Midwest Eye Institute