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CompletedNCT04880928Updated Oct 19, 2021

Comparison Mydriasis by Mydrane With Topical Drop Application

A Phase 4 interventional study of Eye injection (Mydrane) and eye drops (Phenylephrin) in Cataract, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-10-19.

Sponsored by Medical University of Graz · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
50 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract
03

Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    injection solution

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

    Drug: Eye injection (Mydrane)

  • Active comparator
    Standard eye Drops

    Phenylephrine 10% and Tropicamid 0,5% eye drops

    Drug: eye drops (Phenylephrin) · Drug: eye drops (Tropicamid)

Interventions

  • DrugEye injection (Mydrane)

    Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride

    Also known as: Mydrane

  • Drugeye drops (Phenylephrin)

    Phenylephrine 10%

    Also known as: Minims

  • Drugeye drops (Tropicamid)

    Tropicamid 0,5%

    Also known as: Agepha

05

What researchers measure

Primary outcomes

  1. pupil dilating

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

    Time frame: during first and second surgery: a maximum of four weeks between first and second surgery

Secondary outcomes

  1. 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

    Time frame: after first and second surgery: a maximum of four weeks between first and second surgery

  2. 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

    Time frame: after first and second surgery: a maximum of four weeks between first and second surgery

06

Study locations

1 site
  • Medical University Graz
    Graz, 8036, Austria
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04880928
Lead sponsor
Medical University of Graz
Responsible party
Sponsor
First posted
May 11, 2021
Start date
Aug 12, 2020
Primary completion
Sep 23, 2021
Completion
Sep 23, 2021
Last update
Oct 19, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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