Trial reportOphthalmology. Retina2020
Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections.
Trial report in Ophthalmology. Retina, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02872012 (Cryoanesthesia for Intravitreal Injections), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Cryoanesthesia for Intravitreal Injections
Who cites it
6 citing papers in PubMed, 7 citations in OpenAlex.
- Long term evaluation of the safety and efficacy of local cooling anesthesia during intravitreal injections: The COOL-2 Trial.PloS one · 2026Trial
- Cooling Anesthesia for Intravitreal Injection: Results of the Prospective Open-Label, Dose-Ranging COOL-1 Trial.Clinical ophthalmology (Auckland, N.Z.) · 2021Trial
- Impact of an Ophthalmic Cooling Device on Corneal Immune and Sensory Nerve Features in Chronic Ocular Surface Pain: A Prospective, Feasibility Study.Ophthalmology and therapy · 2026Article
- Article
- Cooling Anesthesia for Intravitreal Injections - A Review.Clinical ophthalmology (Auckland, N.Z.) · 2023Review
- Heat Emitting Damage in Skin: A Thermal Pathway for Mechanical Algesia.Frontiers in neuroscience · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
purposeTo test the safety and preliminary efficacy of rapid, nonpharmacologic anesthesia via cooling for intravitreal injections.
designSingle-center, randomized phase 1 dose-ranging safety study (ClinicalTrials.gov identifier, NCT02872012).
participantsAdults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included.
methodsA handheld device was developed to provide anesthesia via cooling to a focal area on the surface of the eye before intravitreal treatment (IVT). In 22 patients undergoing bilateral IVT, 1 eye was randomized to receive standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia at 1 of 5 different temperatures and cooling times. Subjective pain was assessed via the visual analog scale (VAS; range, 1-10) at 2 time points: (1) immediately after IVT and (2) 4 hours after IVT. Treated eyes were assessed for ocular safety 24 hours after IVT.
main outcome measuresWe determined the occurrence of adverse events in eyes treated with cooling anesthesia. Mean VAS pain scores immediately after IVT and 4 hours after IVT in eyes receiving cooling anesthesia were compared with eyes receiving SOC.
resultsA total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC. No dose-related toxicity was found with cooling anesthesia. Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC. The mean±standard error of the mean (SEM) VAS pain scores immediately after intravitreal injection were 2.3 ± 0.4 for patients receiving SOC and 2.2 ± 0.6 in patients receiving -10° C cooling anesthesia (P = 0.8). Mean±SEM pain scores 4 hours after injection were 1.6 ± 0.4 for SOC and 1.2 ± 0.5 in the combined -10° C arms (P = 0.56). Total mean±SEM procedure time was 124 ± 5 seconds for patients treated with cooling anesthesia versus 395 ± 40 seconds for SOC (P < 0.0001).
conclusionsUltra-rapid cooling of the eye for anesthesia was well tolerated, with -10° C treatment resulting in comparable levels of anesthesia to SOC with a reduction in procedure time.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.