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
- 发起方
- 入组人数
- 50
- 主要终点
- Ocular Pain
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
- Single Group
- 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, in OR placement versus 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
Ocular Pain
时间窗: Assessed on Day 7
As measured by ocular pain assessment numerical grading scale (0-10)
Anterior Chamber Cells
时间窗: Assessed on Day 7
As measured by summed ocular inflammation score (0-4)
次要结局
- Percentage with complete absence of cell(Assessed on Day -1, Day 1, Day 7, Day 30)
- Physician ease of insertion and visualization(Assessed on Day 1)
- Percentage with complete absence of pain(Assessed on Day -1, Day 1, Day 7, Day 30)
- Mean change in BCVA(Assessed on Day -1, Day 7, Day 30)
研究者
Joseph Kavanagh, MD
Principal Investigator
Eye Associates of South Texas