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Cooling Anesthesia for Intravitreal Injections - A Review.

ABSTRACT: Intravitreal (IVT) injections are the most common procedure performed in retinal clinics today. It has revolutionized the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular edema, macular edema due to veinous occlusive disease and other forms of exudative maculopathy. Though IVT injections prevent vision loss, the discomfort at the time of the injection has been troublesome to patients. This has led to patients missing their regular and routine dosage of treatment. Various modes of pre-injection anesthetic methods have been tried but in vain. Lidocaine-based topical anesthesia, in the form of pledgets, topical gel or subconjunctival lidocaine injection, has been the standard of care (SOC) for IVT injections worldwide. This article highlights the role of cooling anesthesia in reducing pain, anxiety and discomfort associated with needle penetration at the time of injection. PubMed and MedLine search were related to anesthesia for intravitreal injections, cooling anesthesia, mechanism of cooling anesthesia, COOL-1 trial, COOL-2 trial, results of COOL-1 trial and ultrarapid cooling anesthesia.

SUBMITTER: Chandrasekaran PR

PROVIDER: S-EPMC9844145 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Cooling Anesthesia for Intravitreal Injections - A Review.

Chandrasekaran Priya R PR Aziz Aamir A AA Khan Hannah H Khanani Arshad M AM

Clinical ophthalmology (Auckland, N.Z.) 20230113

Intravitreal (IVT) injections are the most common procedure performed in retinal clinics today. It has revolutionized the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular edema, macular edema due to veinous occlusive disease and other forms of exudative maculopathy. Though IVT injections prevent vision loss, the discomfort at the time of the injection has been troublesome to patients. This has led to patients missing their regular and routine dosage of treatment ...[more]

PMID: 36660308

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Project description: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.

Project description:BackgroundIntravitreal injection (IVI) is a very common vitreoretinal procedure, and multiple injections are often required per patient. This systematic review was conducted to evaluate the effectiveness of various local anesthetic techniques in reducing pain during injection.MethodsA systematic review was conducted based on searches of Cochrane, LILACS, PubMed, Scopus, Web of Science, and the gray literature (Google Scholar). The end search date was February 19, 2016, across all databases. We classified pain by converting visual analog scale (VAS) scores (0-100 mm) into Jensen's classification levels: 0-4, no pain; 5-44, mild pain; 45-74, moderate pain; and 75-100, severe pain. An intervention was considered clinically significant when pain score change was >12 mm on a 100-mm scale.ResultsEight studies out of 23 met the eligibility criteria. The total number of patients was 847. Most studies (5/8 [62.5%]) were at unclear risk of bias because of unclear randomization, thus providing only moderate evidence to this review. The anesthetic techniques included eye drops with proparacaine, tetracaine or cocaine, a lidocaine pledget or gel, and subconjunctival injection of 2% lidocaine or 0.75% levobupivacaine. No study comprised all of the techniques. Pain was mild (VAS scores, 5-44 mm) regardless of anesthetic technique. A clinically significant intervention (pain score change >12 mm) was found for only one study comparing proparacaine drops, lidocaine gel, and subconjunctival lidocaine; in that study, a subconjunctival injection of 2% lidocaine provided the greatest pain reduction. A meta-analysis was not possible due to study heterogeneity.ConclusionsPatient pain during IVI under topical anesthesia is mild regardless of anesthetic technique. A subconjunctival injection of 2% lidocaine could be an option for highly sensitive patients. However, with moderate level of evidence, no single anesthetic technique could be defined as the best option for IVI.

Project description:ImportanceRecently, intravitreal pegcetacoplan became the first drug to gain US Food and Drug Administration approval for the treatment of geographic atrophy associated with nonexudative age-related macular degeneration, but the administration of this medication may be associated with unanticipated posttreatment complications.ObjectiveTo assess the prevalence of presumed silicone oil droplets in the vitreous cavity after intravitreal injection of pegcetacoplan.Design, setting, and participantsThis case series study involved a retrospective record review of all 55 patients treated with intravitreal pegcetacoplan, 0.1 mL in 150-mg/mL solution, between March 24 and June 5, 2023, at a single specialty retina practice. All injections were done using needles from the kit supplied by Apellis Pharmaceuticals on a 1-mL McKesson Luer lock syringe.Main outcomes and measuresThe presence or absence of presumed silicone bubbles detected during dilated biomicroscopic fundus examination and/or on color fundus photographs, the presence or absence of symptoms, change in visual acuity, and/or increase in intraocular pressure.ResultsA total of 62 intravitreal pegcetacoplan injections were given to 55 patients (mean [SD] age, 83.8 [7.8] years; 33 women [60%]) from March 24 to June 5, 2023. Of the 55 patients, 16 (29%; mean [SD] age, 83.8 [7.4] years; 9 women [56%]) had presumed intravitreal silicone droplets discovered 2 to 4 weeks after treatment, 3 of which were documented on color fundus photographs. Of the 16 patients, 14 (88%) were symptomatic for new floaters that they described as persistent, while 2 (13%) were asymptomatic. There were no signs of inflammation or infection, no increases in intraocular pressure, and no changes in visual acuity for all 16 patients.Conclusions and relevanceA substantial percentage of patients had symptomatic floaters from presumed intravitreal silicone oil droplets after injections of pegcetacoplan using a McKesson 1-mL Luer lock syringe. These findings support consideration of informing patients of this potential adverse effect, avoiding use of the McKesson syringe, and considering use of silicone-free syringes for pegcetacoplan injections.

Dataset Information

Cooling Anesthesia for Intravitreal Injections - A Review.

Publications

Cooling Anesthesia for Intravitreal Injections - A Review.

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