Nucci Paolo, Lembo Andrea, Caputo Roberto, Dellavalle Andrea, Serafino Massimiliano, Schiavetti Irene, Pichi Francesco
Department of Clinical Sciences and Community Health, University Eye Clinic, San Giuseppe Hospital-Multimedica, University of Milan, Via San Vittore 12, 20123, Milan, Italy.
Department of Pediatric Ophthalmology, Anna Meyer Children's University Hospital, Florence, Italy.
Int Ophthalmol. 2023 Mar;43(3):989-995. doi: 10.1007/s10792-022-02501-4. Epub 2022 Sep 2.
To demonstrate the safety and efficacy of the intracameral use of tropicamide 0.02%/phenylephrine 0.31%/lidocaine 1% in pediatric cataract surgery, a combination widely used in adult patients but still off-label in children.
Design: two-center, prospective, observational study.
San Giuseppe Hospital, Milan and Meyer Children's Hospital, Florence.
children from 0 to 4 years of age undergoing cataract surgery with or without intraocular IOL implantation, in the absence of clinically significant systemic conditions, history of ocular surgery, concurrent ocular medication, hypersensitivity to any of the substances and post-traumatic cataracts. During the surgery, patients received the combination drug after the primary access to the anterior chamber. Efficacy was evaluated by achieving an adequate mydriasis in order to perform capsulorhexis, while safety was assessed by recording vital signs (heart rate, blood pressure, respiratory rate, temperature) pre- and post-administration of the substance.
This study included 53 surgical procedures of 36 patients: 41 eyes were left aphakic, while 12 eyes received primary IOL implantation. The pupil size was adequate to safely perform capsulorhexis in 52 procedures of 53. The difference in pupil enlargement was significant (6.0 ± 1.14 mm, P = < 0.001). There were no notable changes in vital parameters.
The administration of intracameral tropicamide 0.02%/phenylephrine 0.31%/lidocaine 1% in pediatric cataract surgery is effective for obtaining an adequate mydriasis without any vital parameters changes throughout the procedure.
为证明在小儿白内障手术中前房内使用0.02%托吡卡胺/0.31%去氧肾上腺素/1%利多卡因的安全性和有效性，该组合在成年患者中广泛使用，但在儿童中仍属超适应证用药。
设计：双中心、前瞻性、观察性研究。
米兰圣朱塞佩医院和佛罗伦萨迈耶儿童医院。
年龄在0至4岁之间，接受白内障手术（有或无眼内人工晶状体植入），无临床显著全身疾病、眼部手术史、同时使用眼部药物、对任何一种物质过敏以及外伤性白内障的儿童。手术过程中，患者在前房初次穿刺后接受联合用药。通过实现充分散瞳以进行撕囊来评估疗效，同时通过记录用药前后的生命体征（心率、血压、呼吸频率、体温）来评估安全性。
本研究纳入了36例患者的53例手术：41只眼为无晶状体眼，12只眼接受了一期人工晶状体植入。53例手术中的52例，瞳孔大小足以安全地进行撕囊。瞳孔扩大差异有统计学意义（6.0±1.14毫米，P = <0.001）。生命参数无明显变化。
在小儿白内障手术中前房内给予0.02%托吡卡胺/0.31%去氧肾上腺素/1%利多卡因可有效实现充分散瞳，且整个过程中生命参数无变化。
