Long Term Safety of Cooling Anesthesia for Intravitreal Injection (COOL-2)

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

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.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration; Diabetic Retinopathy; Diabetic Macular Edema; Macular Edema; Anesthesia, Local; Intravitreal Injection
• Intervention / Treatment: Device: Recens Cooling Anesthesia Device

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 -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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • Texas
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 108 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Recens Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): April 2, 2021

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 28, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema; Anesthesia; Macular Degeneration; Intravitreal Injection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Diabetic Retinopathy; Macular Edema; Edema; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: COOL-2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Results of this study will be presented at a national meeting

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No