Long Term Safety of Cooling Anesthesia for Intravitreal Injection

(COOL-2 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Arshad Khanani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Recens Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Arshad Khanani, MD

Principal Investigator

Sierra Eye Associates

Eligibility Criteria

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.

Treatment Details

Interventions

• Recens Cooling Anesthesia Device (Other)

Participant Groups

Group I: -15 degrees Celsius for 15 seconds Experimental Treatment 1 Intervention

Cooling anesthesia device applied to the eye at -15 degrees Celsius for 15 seconds.

Group II: -15 degrees Celsius for 10 seconds Experimental Treatment 1 Intervention

Cooling anesthesia device applied to the eye at -15 degrees Celsius for 10 seconds.

Who Is Running the Clinical Trial?

Recens Medical, Inc.

Lead Sponsor

Trials

2

Recruited

120+