A Phase I Dose Ranging Study Evaluating the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL 1)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Subjective Pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
-5 degrees Celsius for 10 seconds
Intervention: Cooling Anesthesia (Device)
-5 degrees Celsius for 20 seconds
Intervention: Cooling Anesthesia (Device)
-10 degrees Celsius for 10 seconds
Intervention: Cooling Anesthesia (Device)
-10 degrees Celsius for 20 seconds
Intervention: Cooling Anesthesia (Device)
Outcomes
Primary Outcomes
Subjective Pain
Time Frame: 24-48 hours after injection
Pain as measured by the visual analogue scale (VAS). This was used in the previously presented SOLAR study (Clinical trials.gov, NCT01926977). Total range is 0-10, with 0 being no pain, and 10 being unbearable pain.
Number of patients with treatment adverse events as measured by slit lamp examination
Time Frame: 30 minutes after injection
Full slit lamp examination of anterior and posterior segment after intravitreal injection
Secondary Outcomes
- Subject response to needle penetration(Intraoperative (During injection))
- Time to perform intravitreal injection(Intraoperative (injection procedure))