Efficacy and Safety of an Intracameral Combination of Two Mydriatics and an Anesthetic for Phacoemulsification in Complicated Patients

Advantages of intracameral mydriatics have been demonstrated in healthy patients, but safety and efficacy in complicated subjects remain to be assessed.

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.

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.

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.

An intracameral mydriatic solution can be a safe and comfortable tool for inducing and maintaining intraoperative mydriasis and analgesia, even in complicated patients.