Clinical trial NCT03732287: Cooling Anesthesia for Intravitreal Injection
Official title: A Phase I Dose Ranging Study Evaluating the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anesthesia, Local
Intravitreal Injection
Macular Degeneration
Diabetic Macular Edema
Keywords: intravitreal injection
anesthesia
macular degeneration
diabetic macular edema
Lead sponsor: Recens Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-06
Enrollment: 40
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 dose escalation strategy 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 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.

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.

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

Primary outcomes:
measure: Subjective Pain
timeFrame: 24-48 hours after injection
measure: Number of patients with treatment adverse events as measured by slit lamp examination
timeFrame: 30 minutes after injection
Secondary outcomes:
measure: Subject response to needle penetration
timeFrame: Intraoperative (During injection)
measure: Time to perform intravitreal injection
timeFrame: Intraoperative (injection procedure)
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: