Comparison Mydriasis by Mydrane With Topical Drop Application

Prospective Intraindividual Comparison of the Mydriasis of a Standardized Intracameral Anaesthetics With the Topical Preoperative Drop Application in the Uncomplicated Cataract Surgery

The primary aim of the study is to compare the effectiveness of the intracameral application of Mydrane® (standardized combination of Tropicamide 0.02%, Phenylephrine 0.31% and Lidocaine 1%) with the preoperative topical application (Tropicamide 0.5% and Phenylephrine 10%). To evaluate the steadiness of the dilating effect on the pupil, the ratio of eyes without necessity for further pupil dilating procedures to perform the capsulorhexis is assessed.

Inclusion Criteria:

• Male and female patients between the age of 50 to 100 years
• Day-hospital and inpatient care
• Clinically significant opacity of the lens with indication for cataract surgery on both eyes
• Lack of previous ophthalmic surgeries
• Lack of relevant ophthalmic conditions: Pseudoexfoliation syndrome, eye injuries, present inflammation (in terms of uveitis, endophthalmitis and iridocyclitis), restricted mydriasis (pupil diameter below 7mm after application of tropicamide 0.38% and phenylephrine HCL 2.5% - at preoperative examination), elevated intraocular pressure, alpha-receptor inhibitor intake (e.g. tamsulosin) due to impeded mydriasis

Exclusion Criteria:

• Allergic to phenylephrine, tropicamide, sodium metabisulfite, disodium edetate, sodium hydroxide, hydrochloric acid, lidocaine hydrochloride, sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate
• Allergic to anesthesia (amide type)
• Allergic to atropine derivates
• Heart disease, tachycardia, hypertensive crises
• Aneurism of big vessels
• Untreated hyperthyroidism
• Untreated closed angle glaucoma and narrow angles with tendencies to glaucoma by intake of mydriatic drugs
• Pregnancy, breast feeding and premenopausal women