Clinical Trials Directory

Trials / Completed

CompletedNCT04880928

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Medical University of Graz · Academic / Other
Sex
All
Age
50 Years – 100 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGEye injection (Mydrane)Mydrane 0.2 mg/ml + 3.1 mg/ml \+ 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride
DRUGeye drops (Phenylephrin)Phenylephrine 10%
DRUGeye drops (Tropicamid)Tropicamid 0,5%

Timeline

Start date
2020-08-12
Primary completion
2021-09-23
Completion
2021-09-23
First posted
2021-05-11
Last updated
2021-10-19

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT04880928. Inclusion in this directory is not an endorsement.