Skip to main content
OpenTrials
Completed

NCT Number: NCT04880928

Comparison Mydriasis by Mydrane With Topical Drop Application

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Graz

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eye injection (Mydrane)

Drug

Mydrane 0.2 mg/ml + 3.1 mg/ml

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

Other names: Mydrane

eye drops (Phenylephrin)

Drug

Phenylephrine 10%

Other names: Minims

eye drops (Tropicamid)

Drug

Tropicamid 0,5%

Other names: Agepha

Primary outcomes

  1. pupil dilating

    Time frame: 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 outcomes

  1. subjective highest intraoperative pain

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 11, 2021
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.