Clinical trial NCT03956797: Long Term Safety of Cooling Anesthesia for Intravitreal Injection
Official title: Long Term Evaluation of the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Intravitreal Injection
Macular Edema
Macular Degeneration
Diabetic Retinopathy
Diabetic Macular Edema
Keywords: Intravitreal Injection
Anesthesia
Macular Degeneration
Diabetic Macular Edema
Lead sponsor: Recens Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A long term safety, dose escalation study design of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection.
Primary purpose: TREATMENT

Brief 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.

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.

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.
* 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.

Primary outcomes:
measure: Pain of Intravitreal Injection: VAS
timeFrame: Immediately after injection
measure: Incidence of Anesthesia-Related Adverse Events
timeFrame: 30 minutes after injection
Secondary outcomes:
measure: Patient Movement During Intravitreal Injection
timeFrame: During injection
measure: Time
timeFrame: Time for entire intravitreal injection procedure
measure: Patient Anesthetic Preference
timeFrame: 24-48 hours after injection
measure: Pain of Intravitreal Injection (Follow-Up): VAS
timeFrame: 24-48 hours after injection
Other outcomes:
Locations:
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
Study officials:
affiliation: Sierra Eye Associates
name: Arshad Khanani, MD
role: PRINCIPAL_INVESTIGATOR
References: