Patient-reported complications after intravitreal injection and their predictive factors.

Abstract Objective The intravitreal injection (IVI) of pharmacological agents is the most commonly performed ocular procedure and is associated with a host of complications. The majority of IVI-related complications data is derived from randomized controlled clinical trials, which report a high adverse event rate. The nature of these protocol-driven trials limit their applicability to the diverse circumstances seen in routine clinical practice. The goal of this study is to determine the prevalence of patient reported IVI-related complications, their risk factors, and the manner in which patients presented in a tertiary eye care center. Design A retrospective, IRB-approved review. Subjects, Participants and/or Controls 44,734 injections in 5,318 unique patients at the Cleveland Clinic Cole Eye Institute from 2012-2016. Methods, Intervention, or Testing Intravitreal injection. Main Outcome Measures Complication occurrence within 15 days of injection. Results From 2012-2016, a total of 44,734 injections were performed in 5,318 unique patients. Overall, complication rates were low, representing 1.9% of all injections, with 1031 unique complications in 685 (12.9%) patients. The most common minor complications, or those not requiring intervention, were irritation (n=312) and subconjunctival hemorrhage (n=284). The most common serious complications, or those requiring intervention, were corneal abrasion (n=46) and iritis (n=31). The majority of complications (66%) were adequately managed by a telephone/Epic electronic message encounter only. Importantly, no injection protocol parameter, such as type of anesthesia, preparation, or post-injection medication, increased the risk of a complication. However, patient sex, age, number of previous injections, and provider strongly influenced the risk of patient-reported complications. Conclusions Overall, complication rates seen in routine clinical practice were low compared to clinical trial reporting. Providers should feel confident in the safety and administration of IVI during times when follow-up office visits and resources may be limited. When performing an IVI, factors such as a patient’s sex, age, number of previous injections, and provider must be taken into account to ensure the best possible outcomes.