Abstract
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.
Highlights
The cataract has a relevant socio-economic impact, if we consider its prevalence and the progressive increase in incidence, along with the European population ageing
This study showed that the intracameral mydriatic is an efficient and safe method for inducing and maintaining intraoperative mydriasis and analgesia, leading to increased patients’ comfort and surgeon satisfaction, as well [3]
Several studies on animal models reported the tolerability at the level of the corneal endothelium of intracameral solutions of phenylephrine, tropicamide and lidocaine, even as a fixed combination [7 - 9]
Summary
The cataract has a relevant socio-economic impact, if we consider its prevalence and the progressive increase in incidence , along with the European population ageing. An optimised cataract surgery should reduce the impact on healthcare resources. Major advantages of intracameral mydriatics in comparison with the topical regimen (which, in many cases, needs multiple administrations in order to achieve adequate effects) have been already demonstrated: single-use, limited ocular surface toxicity and decreased incidence of cardiovascular side effects [1]. Some pilot studies have reported safety and efficacy of various ad hoc intracameral formulations for cataract surgery, prepared “on site”, containing phenylephrine and cyclopentolate or tropicamide [2]. Advantages of intracameral mydriatics have been demonstrated in healthy patients, but safety and efficacy in complicated subjects remain to be assessed
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