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).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Participants With Complete Absence of Ocular Pain at Day 8
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) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
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) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be eligible for study participation if they:
- •Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy.
- •Are willing and able to comply with clinic visits and study related procedures.
- •Are willing and able to sign the informed consent form.
- •Not pregnant.
排除标准
- •Subjects are not eligible for study participation if they:
- •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.
- •Have active infectious systemic disease.
- •Have active infectious ocular or extraocular disease.
- •Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis).
- •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 an/or oral steroids.
- •Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.
研究组 & 干预措施
Lower Punctum Insertion (Group 1)
DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use
Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Upper Punctum Insertion (Group 2)
DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use
Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
结局指标
主要结局
Participants With Complete Absence of Ocular Pain at Day 8
时间窗: at Day 8
Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.
Participants With Zero Cells on Day 14
时间窗: at Day 14
Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).
次要结局
- Ease of Insertion(Day 0)
- Attempts to Achieve Successful Insertion(Day 0)
研究者
Dr. Patrick Spencer
Principal Investigator
Iworks Laser and Vision Center