Status:
COMPLETED
Comparison Mydriasis by Mydrane With Topical Drop Application
Lead Sponsor:
Medical University of Graz
Conditions:
Cataract
Eligibility:
All Genders
50-100 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04880928
Start Date
August 12 2020
End Date
September 23 2021
Last Update
October 19 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University Graz
Graz, Austria, 8036