Intracameral mydriatic-anaesthetic combination performs as expected in real-world setting
The intracameral mydriatic and anaesthetic Mydrane (Théa Pharmaceuticals) appears to provide fast and stable mydriasis during cataract surgery in the great majority of cases, according the findings of an observational register trial, said Dariusz Kęcik MD, PhD, Medical University of Warsaw, Poland.
“The study’s results confirm that stable mydriasis may be achieved after a single, intracameral administration of Mydrane at the beginning of cataract surgery, without preoperative dilatation in a real-world setting,” Prof Kęcik told the 22nd ESCRS Winter Meeting in Belgrade, Serbia.
The trial commenced in February 2017 and included 307 patients who underwent cataract surgery at seven university clinics in Poland. The patients’ co-morbidity profile was typical of the age-group usually referred for cataract. Forty-one patients had glaucoma, 13 had dry AMD, six had neovascular AMD and 36 had other eye diseases. Non-ocular comorbidities included hypertension in 241 patients, diabetes in 72, prostate disease in 29 and depression in 17.
All eyes had pupils that were capable of dilatation to 6.0mm or more during preoperative assessment. The participating surgeons recorded patients’ pupil diameters just prior to the intracameral injection of Mydrane and at key moments of the operation. In addition, immediately after surgery, the operating surgeons’ recorded their opinions on the time to obtain mydriasis and the stability of mydriasis on a five-point Likert Scale, Prof Kęcik explained.
The researchers found that the mean pupil diameter was 2.35mm prior to dilatation, 7.0mm just before capsulorhexis, 6.9mm just before implantation of the intraocular lens and 6.6mm just before the end of the surgery, Prof Kęcik said.
In 92% of procedures, surgeons reported that they agreed or strongly agreed that mydriasis was obtained quickly after administration, and in only 1% of procedures did surgeons strongly disagree. In addition, in 88% of procedures, surgeons said that they agreed or strongly agreed that mydriasis remained stable throughout the operation.
Mydrane was introduced to the market in 2015. It is the first ready-to-use, standardised, commercially manufactured intracameral mydriatic-anaesthetic combination indicated for cataract surgery. It is now approved in several European countries, including Poland. It contains tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% and is designed for intracameral administration directly after
the first cataract surgery incision.
“Mydriasis obtained during cataract surgery was fast and stable in nearly 90% of cases in the opinion of surgeons,” Prof Kęcik added.