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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Drug: Eye injection (Mydrane); Drug: eye drops (Phenylephrin); Drug: eye drops (Tropicamid)

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: injection solution; Mydrane, Tropicamid 0,02%, Phenylephrine 0,31%, Lidocain 1%, injection solution	Drug: Eye injection (Mydrane); Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride; Other Names: Mydrane
Active Comparator: Standard eye Drops; Phenylephrine 10% and Tropicamid 0,5% eye drops	Drug: eye drops (Phenylephrin); Phenylephrine 10%; Other Names: Minims; Drug: eye drops (Tropicamid); Tropicamid 0,5%; Other Names: Agepha

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pupil dilating	The frequency of the feasibility of capsulorhexis without additional pupil dilating actions	during first and second surgery: a maximum of four weeks between first and second surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective highest intraoperative pain	Highest intraoperative pain visualized on a visual analogue scale (VAS) asked by a questionnaire, with the minimum 1 and maximum 10 , where higher scores mean a worse outcome	after first and second surgery: a maximum of four weeks between first and second surgery
subjective perception of anesthetic procedures	perception of anesthetic procedures visualized on a visual analogue scale (VAS) asked by a questionnaire, with the minimum 1 and maximum 10 , where higher scores mean a worse outcome	after first and second surgery: a maximum of four weeks between first and second surgery

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): September 23, 2021
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Pupil Disorders; Cataract; Mydriasis; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: Mydriasis with Mydrane

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No