Long Term Safety of Cooling Anesthesia for Intravitreal Injection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long Term Evaluation of the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL-2)

Conditions
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Anesthesia, Local, Intravitreal Injection, Macular Edema, Macular Degeneration, Diabetic Retinopathy, Diabetic Macular Edema

Intervention / Treatment
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* Device: Recens Cooling Anesthesia Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A long term safety, dose escalation study design of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: -15 degrees Celsius for 10 seconds<br>Cooling anesthesia device applied to the eye at -15 degrees Celsius for 10 seconds. | Device: Recens Cooling Anesthesia Device<br>* Application of cooling anesthesia device prior to intravitreal injection<br>|
| Experimental: -15 degrees Celsius for 15 seconds<br>Cooling anesthesia device applied to the eye at -15 degrees Celsius for 15 seconds. | Device: Recens Cooling Anesthesia Device<br>* Application of cooling anesthesia device prior to intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain of Intravitreal Injection: VAS | Pain of intravitreal injection as measured by 10-point visual analog scale (VAS) (0 meaning no pain, 10 meaning the most severe pain). | Immediately after injection | 
| Incidence of Anesthesia-Related Adverse Events | % of patients that experience cooling anesthesia device-related adverse events, as assessed by anterior segment and posterior segment examination. | 30 minutes after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Movement During Intravitreal Injection | Physician's evaluation of the subject's movement during the intravitreal injection procedure in response to needle penetration (0 = no movement, 1 = mild movement, 2 = marked movement). | During injection | 
| Time | Recording of the time it takes to perform intravitreal injection procedure. | Time for entire intravitreal injection procedure | 
| Patient Anesthetic Preference | Patient response to a questionnaire asking which method of anesthesia they prefer: standard of care or the cooling anesthesia device. | 24-48 hours after injection | 
| Pain of Intravitreal Injection (Follow-Up): VAS | Pain of intravitreal injection as measured by 10-point visual analog scale (0 meaning no pain, 10 meaning the most severe pain) during follow-up phone call. | 24-48 hours after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravitreal Injection, Anesthesia, Macular Degeneration, Diabetic Macular Edema