Efficacy and safety of an intracameral combination of two mydriatics and an anesthetic for phacoemulsification in complicated patients

Background: Advantages of intracameral mydriatics have been demonstrated in healthy patients, but safety and efficacy in complicated subjects remain to be assessed. Objective: The purpose of this study is to evaluate efficacy and safety of an intracameral combination of phenylephrine (0.31%), tropicamide (0.02%) and lidocaine (1%) (Mydrane®, Thea Inc.) in phacoemulsification surgery in subgroups of patients affected by different systemic and ocular diseases. Methods: 125 patients were recruited and compared with a control group of 39 patients. Both groups have been divided according to the presence/absence of ocular or systemic diseases. In course of surgery, grade of mydriasis and ocular analgesia have been evaluated by the surgeon. During follow-up, eventual adverse events have been monitored. Also, comfort reported by patients and surgeon has been investigated. Results: 99.2% of patients receiving the intracameral formulation achieved acceptable mydriasis (> 6 mm), maintained during capsulorhexis, phacoemulsification and IOL insertion without the need of additional mydriatics. No adverse events or sings of unsuccessful surgery were observed among treated patients. Conclusion: An intracameral mydriatic solution can be a safe and comfortable tool for inducing and maintaining intraoperative mydriasis and analgesia, even in complicated patients.