Comparison Mydriasis by Mydrane With Topical Drop Application

• Status: Completed
• Trial end date: 2021-09-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Ophthalmic Solutions

Criteria

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