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

Recens Medical

Status

Completed

Conditions

Intravitreal Injection

Anesthesia, Local

Diabetic Macular Edema

Macular Degeneration

Macular Edema

Diabetic Retinopathy

Treatments

Device: Recens Cooling Anesthesia Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03956797

COOL-2.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 110 years old

Volunteers

No 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 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.