Cooling Anesthesia for Intravitreal Injection
Completed · Phase 1/Phase 2
Conditions studied: Anesthesia, Local, Intravitreal Injection, Macular Degeneration, Diabetic Macular Edema
In brief
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.
Key facts
- Study ID
- NCT03732287
- Run by
- Recens Medical, Inc.
- People needed
- 40
- Starts
- 2018-11-30
- Expected to finish
- 2019-04-26
- Last updated by the study team
- 2020-05-27
Who can join
Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Sierra Eye Associates — Reno, Nevada, United States
- Retina Consultants of Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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