A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL) Compared to Insertion 1-day Post-op - The SITE Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Anterior Chamber Cells
研究概览
简要总结
To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.
详细描述
This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.
There will be approximately 50 eyes with two groups:
Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD.
Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be eligible for study participation if they:
- •Are an adult subject aged 65 years or older Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes Are willing and able to comply with clinic visits and study related procedures Are willing and able to sign the informed consent form
排除标准
- •Subjects are not eligible for study participation if they:
- •Have active infectious systemic disease Have active infectious ocular or extraocular disease Have unobstructed nasolacrimal duct in the study eye(s) Have known hypersensitivity to dexamethasone or are a known steroid responder Have a history of ocular inflammation or macular edema Are currently being treated with immunomodulating agents in the study eye(s) Are currently being treated with immunosuppressants and/or oral steroids Are currently being treated with corticosteroid implant (i.e. Ozurdex) Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye Have a history of complete punctal occlusion in one or both punctum Currently use topical ophthalmic steroid medications Are unwilling or unable to comply with the study protocol Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
研究组 & 干预措施
Dexamethasone Ophthalmic Insert Day of Surgery
Day of surgery, in OR placement
干预措施: Dexamethasone 0.4 MG [Dextenza] (Drug)
Dexamethasone Ophthalmic Insert Day 1 Post Op
Day 1 Post-Op, In-office (HOPD)
干预措施: Dexamethasone 0.4 MG [Dextenza] (Drug)
结局指标
主要结局
Anterior Chamber Cells
时间窗: Assessed on Day 7
As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome)
Ocular Pain
时间窗: Assessed on Day 7
As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome)
次要结局
- Mean change in BCVA(Assessed on Day -1, Day 7, Day 30)
- Physician ease of insertion and visualization(Assessed on Day 1)
- Percentage with complete absence of cell(Assessed on Day -1, Day 1, Day 7, Day 30)
- Percentage with complete absence of pain(Assessed on Day -1, Day 1, Day 7, Day 30)