Evaluation of the Efficacy and Safety of Intracameral Phenylephrine Hydrochloride, Tropicamide, and Lidocaine Hydrochloride in Pediatric Cataract Surgery

The primary objective of the study is the evaluation of the **efficacy** and **safety** of Mydrane in children undergoing cataract surgery. This is clinically relevant as pediatric cataract can significantly impair vision, and effective management is crucial for visual development. The study aims to assess whether Mydrane, a combination of phenylephrine hydrochloride, tropicamide, and lidocaine hydrochloride, can provide adequate mydriasis and anesthesia during the surgical procedure, minimizing systemic side effects and improving surgical outcomes.

The clinical trial focuses on evaluating the efficacy and safety of Mydrane in children diagnosed with **pediatric cataract**. The study population includes both male and female participants, ranging in age from 8 weeks to 17 years, who are scheduled for surgical cataract repair of one or both eyes. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their medical condition and the requirement for surgical intervention, with no additional lifestyle considerations specified. The trial aims to gather data on the pediatric use of Mydrane, contributing to the understanding of its application in this demographic.

The clinical trial is designed to evaluate the **efficacy** and safety of Mydrane, a solution for injection, in children undergoing cataract surgery. The trial employs a randomized, double-blind, controlled design to ensure unbiased results. The study is categorized as low-intervention, as it involves minimal additional risk compared to standard clinical practice. The trial is expected to last from July 1, 2023, to August 10, 2023, with recruitment having started on July 1, 2023. Participants will be involved in the study for a maximum treatment period of one day, as the intervention is administered intraoperatively.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is assessed based on criteria such as age (8 weeks to 17 years) and the need for surgical cataract repair. The primary endpoint is achieving sufficient pupillary dilatation to perform surgery without mechanical dilatation, while secondary endpoints include monitoring heart rate and blood pressure. Follow-up visits are not specified, as the intervention is limited to the surgical procedure itself. The end-of-study visit coincides with the completion of the surgical procedure and the collection of any necessary data.

Participants may be terminated early from the study if they do not meet the inclusion criteria, experience adverse reactions, or if the study is discontinued for any reason. The trial aims to provide valuable insights into the use of Mydrane in pediatric cataract surgery, contributing to the understanding of its safety and effectiveness in this population.

The clinical trial involves the administration of **Mydrane**, a combination solution for injection, containing **phenylephrine hydrochloride**, **tropicamide**, and **lidocaine hydrochloride**. This pharmaceutical product is formulated as a solution for injection and is intended for **intraocular use**. The concentration of the active substances in the solution is 0.2 mg/ml of phenylephrine hydrochloride, 3.1 mg/ml of tropicamide, and 10 mg/ml of lidocaine hydrochloride. The maximum daily dose and total dose amount to 0.2 ml, with the treatment period limited to a single day. The administration of Mydrane is conducted under controlled conditions to ensure precise dosing and participant safety.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified for this study. The trial focuses solely on evaluating the efficacy and safety of Mydrane in the pediatric population undergoing cataract surgery. Compliance with the dosing schedule is monitored through standard clinical trial procedures to ensure adherence to the protocol and to assess the outcomes accurately.

The efficacy of the clinical trial will be assessed by evaluating the primary endpoint of sufficient pupillary dilatation to perform surgery without mechanical dilatation. This parameter is crucial for determining the effectiveness of Mydrane in achieving the desired surgical conditions in pediatric patients undergoing cataract surgery. The secondary endpoints include monitoring **heart rate** and blood pressure, which will provide additional insights into the systemic effects of the treatment. These efficacy parameters will be measured and collected at specified timepoints during the surgical procedure to ensure accurate and reliable data collection. The analysis of these endpoints will be conducted using appropriate statistical methods to determine the efficacy of Mydrane in the specified pediatric population.