COOL-1: Cooling Anesthesia for Intravitreal Injection

Sponsor

Recens Medical, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03732287

Collaborator

(none)

Enrollment

Locations

Arms

4.8

Actual Duration (Months)

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to evaluate the safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device and determine the effects of temperature and duration of application on subjective pain after intravitreal injection.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local Intravitreal Injection Macular Degeneration Diabetic Macular Edema	Device: Cooling Anesthesia	Phase 1/Phase 2

Detailed Description

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 -10 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.

This dose escalation study will test various temperatures and duration of temperatures to evaluate for safety as well as determine the optimal temperature for anesthesia during intravitreal injection.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

A dose escalation strategy of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injectionA dose escalation strategy of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Dose Ranging Study Evaluating the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL 1)

Actual Study Start Date :

Nov 30, 2018

Actual Primary Completion Date :

Apr 26, 2019

Actual Study Completion Date :

Apr 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: -5 degrees Celsius for 10 seconds	Device: Cooling Anesthesia Application of cooling anesthesia device prior to intravitreal injection
Experimental: -5 degrees Celsius for 20 seconds	Device: Cooling Anesthesia Application of cooling anesthesia device prior to intravitreal injection
Experimental: -10 degrees Celsius for 10 seconds	Device: Cooling Anesthesia Application of cooling anesthesia device prior to intravitreal injection
Experimental: -10 degrees Celsius for 20 seconds	Device: Cooling Anesthesia Application of cooling anesthesia device prior to intravitreal injection

Outcome Measures

Primary Outcome Measures

Subjective Pain [24-48 hours after injection]
Pain as measured by the visual analogue scale (VAS). This was used in the previously presented SOLAR study (Clinical trials.gov, NCT01926977). Total range is 0-10, with 0 being no pain, and 10 being unbearable pain.
Number of patients with treatment adverse events as measured by slit lamp examination [30 minutes after injection]
Full slit lamp examination of anterior and posterior segment after intravitreal injection

Secondary Outcome Measures

Subject response to needle penetration [Intraoperative (During injection)]
subject response to needle penetration as evaluated by physician
Time to perform intravitreal injection [Intraoperative (injection procedure)]
Time to perform injection, measured from beginning of anesthesia to intravitreal injection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 Xiidra drops.
History of Endophthalmitis with intravitreal injection
History of uveitis
History of retinal detachment in either eye
History of vitrectomy