Long Term Evaluation of the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Incidence of Anesthesia-Related Adverse Events
研究概览
简要总结
The purpose of this clinical study is to evaluate the long term safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device.
详细描述
Intravitreal injections have become the standard of care for administering medications for retinal diseases such as age related macular degeneration and diabetic macular edema.
There is considerable apprehension among patients receiving these injections, primarily revolving around adequate anesthesia during the injection. Current methods of anesthesia involve topical anesthetic drops, lidocaine gels, or subconjunctival injections of lidocaine, which suffer from either poor anesthetic effect, corneal irritation, or subconjunctival hemorrhage, as well as significant time for the onset of anesthesia.
Recens Medical has developed a novel medical device which can precisely and rapidly cool the surface of the eye This device cools to a temperature around -5 to -15 degrees Celsius, about the temperature of a cold ice cube, and thus has an excellent safety profile compared to conventional ophthalmic cryotherapy units. The value of such a device is both improved patient comfort, as well as increased efficiency and workflow for retina specialists administering intravitreal injections.
This device has been extensively tested in animal safety studies as well as pilot human studies and has not demonstrated any serious adverse effects and has shown anesthetic effects comparable to current standard of care.
The purpose of this clinical study is to evaluate the long term safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women > 18 years old at screening visit.
- •Men and women who are undergoing intravitreal injections in either one eye or both eyes with either Lucentis or Eylea as part of their normal standard of care with a 30 gauge needle.
- •Subject has received a minimum of 3 intravitreal injections in the study eye prior to the study visit.
- •Subject is willing and able to sign the study written informed consent form (ICF).
排除标准
- •History of presence of scleromalacia
- •Preexisting conjunctival, episcleral or scleral defects
- •Less than 18 years of age
- •Unable to provide informed consent
- •Has received less than 3 injections in the study eye
- •Active severe eye disease not controlled with artificial tears and requiring Restasis or other prescription drugs for dry eye.
- •History of Endophthalmitis with intravitreal injection
- •History of uveitis
- •History of retinal detachment in either eye
- •History of vitrectomy
- •Subjects who received administration of cooling anesthesia as part of the COOL-1 study will not be excluded and are eligible to participate in this study.
结局指标
主要结局
Incidence of Anesthesia-Related Adverse Events
时间窗: 30 minutes after injection
% of patients that experience cooling anesthesia device-related adverse events, as assessed by anterior segment and posterior segment examination.
Pain of Intravitreal Injection: VAS
时间窗: Immediately after injection
Pain of intravitreal injection as measured by 10-point visual analog scale (VAS) (0 meaning no pain, 10 meaning the most severe pain).
次要结局
- Time(Time for entire intravitreal injection procedure)
- Patient Anesthetic Preference(24-48 hours after injection)
- Pain of Intravitreal Injection (Follow-Up): VAS(24-48 hours after injection)
- Patient Movement During Intravitreal Injection(During injection)