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Comparison Mydriasis by Mydrane With Topical Drop Application

NCT ID: NCT04880928

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-12

Study Completion Date

2021-09-23

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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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injection solution

Mydrane, Tropicamid 0,02%, Phenylephrine 0,31%, Lidocain 1%, injection solution

Group Type EXPERIMENTAL

Eye injection (Mydrane)

Intervention Type DRUG

Mydrane 0.2 mg/ml + 3.1 mg/ml

\+ 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride

Standard eye Drops

Phenylephrine 10% and Tropicamid 0,5% eye drops

Group Type ACTIVE_COMPARATOR

eye drops (Phenylephrin)

Intervention Type DRUG

Phenylephrine 10%

eye drops (Tropicamid)

Intervention Type DRUG

Tropicamid 0,5%

Interventions

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Eye injection (Mydrane)

Mydrane 0.2 mg/ml + 3.1 mg/ml

\+ 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride

Intervention Type DRUG

eye drops (Phenylephrin)

Phenylephrine 10%

Intervention Type DRUG

eye drops (Tropicamid)

Tropicamid 0,5%

Intervention Type DRUG

Other Intervention Names

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Mydrane Minims Agepha

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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Mydriasis with Mydrane

Identifier Type: -

Identifier Source: org_study_id