A Randomized Controlled Clinical Trial aSsessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert When Placed Within the Upper Eye Lid Canaliculus in Comparison to the Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With Posterior Chamber Intraocular Lens Implant (CE/PCIOL).
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Post-operative inflammation scores
研究概览
简要总结
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
详细描述
Randomized controlled clinical trial assessing the efficacy of DEXTENZA, sustained release dexamethasone 0.4 mg insert when placed within the upper eye lid canaliculus in comparison to the lower lid canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lens implant (CE/PCIOL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Been diagnosed with clinically significant cataract and CE/PCIOL has been planned
- •Bilateral cataract surgery with IOL has been planned
- •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
- •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)
- •History of prior ocular surgery, excluding Lasik or PRK
- •History of ocular inflammation or macular edema
- •Use of any systemic NSAIDs greater than 375 mg per day
- •Patients being treated with immunosuppressants and/or oral steroids
- •Patients with a corticosteroid implant (i.e. Ozurdex)
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
研究组 & 干预措施
DEXTENZA placed within the upper canaliculus
Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
DEXTENZA placed within the lower canaliculus
Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
结局指标
主要结局
Post-operative inflammation scores
时间窗: Assessed on Days 1, 7, 30 for change
As measured on a scale of 0-4: absence of cell to be defined as a grade of 0-0.5, absence of flare to be defined as a grade of 0-1.
Post-op pain scores
时间窗: Assessed on Days 1, 7, 30 for change
As measured on a scale from 0-10
次要结局
- Ease of Insertion (successful implantation)(Assessed on Day 0 (Day of Insertion))
- Intraocular Pressure(Assessed on Days 1, 7, 30, 90 for change)
- Need of additional steroids(Assessed on Days 1, 7, 30, 90 for change)
- Patient reported outcomes(Assessed on Day 90)
- Absence of CME(Assessed on Day -30 to -1 and Day 90 for change)
- Absence of rebound iritis(Assessed on Days 1, 7, 30, 90 for change)
- Visual Outcome(Assessed at all time points;comparison of Day 30 vs Day 90)
研究者
Kerry Assil, MD
Sponsor-Investigator, Principal Investigator
Assil Eye Institute