Long Term Safety of Cooling Anesthesia for Intravitreal Injection

Diabetic Retinopathy Clinical Trial

— COOL-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956797
• Other study ID #: COOL-2.0
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: April 2, 2021

Study information

• Verified date: August 2022
• Source: Recens Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Recens Cooling Anesthesia Device
Application of cooling anesthesia device prior to intravitreal injection

Locations

Country	Name	City	State
United States	Retina Consultants of Houston	Houston	Texas
United States	Sierra Eye Associates	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Recens Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Time	Recording of the time it takes to perform intravitreal injection procedure.	Time for entire intravitreal injection procedure
Secondary	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
Secondary	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