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-15 degrees Celsius for 10 seconds for Age-Related Macular Degeneration (COOL-2 Trial)
N/A
Waitlist Available
Led By Arshad Khanani, MD
Research Sponsored by Recens Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after injection
Awards & highlights
Summary
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.
Eligible Conditions
- Age-Related Macular Degeneration
- Diabetic Retinopathy
- Diabetic Macular Edema
- Local Anesthesia
- Intravitreal Injections
- Macular Edema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-48 hours after injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours after injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Anesthesia-Related Adverse Events
Pain of Intravitreal Injection: VAS
Secondary study objectives
Pain of Intravitreal Injection (Follow-Up): VAS
Patient Anesthetic Preference
Patient Movement During Intravitreal Injection
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: -15 degrees Celsius for 15 secondsExperimental Treatment1 Intervention
Cooling anesthesia device applied to the eye at -15 degrees Celsius for 15 seconds.
Group II: -15 degrees Celsius for 10 secondsExperimental Treatment1 Intervention
Cooling anesthesia device applied to the eye at -15 degrees Celsius for 10 seconds.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Recens Cooling Anesthesia Device
2019
N/A
~80
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Who is running the clinical trial?
Recens Medical, Inc.Lead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Arshad Khanani, MDPrincipal InvestigatorSierra Eye Associates
5 Previous Clinical Trials
994 Total Patients Enrolled
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