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Comparison Mydriasis by Mydrane With Topical Drop Application

Sponsor
Medical University of Graz (Other)
Overall Status
Completed
CT.gov ID
NCT04880928
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
13.4
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Eye injection (Mydrane)
  • Drug: eye drops (Phenylephrin)
  • Drug: eye drops (Tropicamid)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Prospective Intraindividual Comparison of the Mydriasis of a Standardized Intracameral Anaesthetics With the Topical Preoperative Drop Application in the Uncomplicated Cataract Surgery
Actual Study Start Date :
Aug 12, 2020
Actual Primary Completion Date :
Sep 23, 2021
Actual Study Completion Date :
Sep 23, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pupil dilating [during first and second surgery: a maximum of four weeks between first and second surgery]

      The frequency of the feasibility of capsulorhexis without additional pupil dilating actions

    Secondary Outcome Measures

    1. subjective highest intraoperative pain [after first and second surgery: a maximum of four weeks between first and second surgery]

      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

    2. subjective perception of anesthetic procedures [after first and second surgery: a maximum of four weeks between first and second surgery]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University Graz Graz Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT04880928
    Other Study ID Numbers:
    • Mydriasis with Mydrane
    First Posted:
    May 11, 2021
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Mydriasis
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Oct 19, 2021