June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
A Novel Rapid Cooling Device for Intravitreal Injection Anesthesia: Results of the Prospective COOL-2 Study
Author Affiliations & Notes
  • Daniel L Chao
    Viterbi Family Department of Ophthalmology, Shiley Eye Institute, UC San Diego, La Jolla, California, United States
  • Charles Clifton Wykoff
    Retina Consultants of Houston, Texas, United States
  • Arshad M. Khanani
    Sierra Eye Associates, Nevada, United States
  • Gunho Kim
    Recens Medical Inc., Korea (the Republic of)
  • Footnotes
    Commercial Relationships   Daniel Chao, Apellis (F), Chengdu Pharmaceuticals (F), DTx Pharma (C), Genentech (F), Ionis Pharmaceuticals (F), National Eye Institute (F), Recens Medical (C), Visgenx (C), Visgenx (P); Charles Wykoff, Recens Medical (F), Recens Medical (C); Arshad Khanani, Recens Medical (F), Recens Medical (C); Gunho Kim, Recens Medical inc (P), Recens Medical Inc (E)
  • Footnotes
    Support  Recens Medical
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 4196. doi:
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      Daniel L Chao, Charles Clifton Wykoff, Arshad M. Khanani, Gunho Kim; A Novel Rapid Cooling Device for Intravitreal Injection Anesthesia: Results of the Prospective COOL-2 Study. Invest. Ophthalmol. Vis. Sci. 2020;61(7):4196.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To evaluate the safety & efficacy of a novel cooling device capable of achieving ocular surface anesthesia within 10 seconds prior to intravitreal injection (IVT).

Methods : Results from an ongoing, multicenter, open-label study evaluating repeated cooling anesthesia administrations will be presented (COOL-2; NCT03956797). Key inclusion criteria were patients receiving intravitreal anti-vascular endothelial growth factor injections who had received at least 3 prior IVT. Key exclusion criteria were a history of ocular inflammation or previous retinal surgery. Cooling anesthesia was applied in lieu of their regular anesthesia, and pain was recorded as part of the visual analog scale at time of injection, 5 minutes post injection, and 24-48 hours post injection. Comprehensive slit lamp examination and indirect ophthalmoscopy were performed 30 minutes post injection. Adverse events and time to perform intravitreal injection were recorded. Patient reported preference for anesthesia type was captured. Enrolled patients are planned to receive cooling anesthesia for 12 repeated administrations longitudinally.

Results : Currently, over 50 patients have been enrolled with a mean of 3.1 cooling applications per patient (166 cooling applications total). There have been no serious adverse events thus far. Nonserious AEs include 19% incidence of subconjunctival hemorrhage due to IVT. Pain during IVT, as measured by visual analog scale, was not significantly different compared to historical controls and similar to standard of care anesthesia. 70% of subjects reported preference for cooling anesthesia compared to their prior anesthesia method (subconjunctival lidocaine). Total anesthesia+IVT time with cooling was less than 2 minutes, significantly shorter than that required for subconjunctival lidocaine.

Conclusions : Cooling anesthesia for IVT can be a safe and effective anesthetic method which may improve the intravitreal injection experience for patients as well as improve workflow efficiency for clinicians.

This is a 2020 ARVO Annual Meeting abstract.

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