Comparison Mydriasis by Mydrane With Topical Drop Application

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Drug: Eye injection (Mydrane)
* Drug: eye drops (Phenylephrin)
* Drug: eye drops (Tropicamid)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |