Comparison Mydriasis by Mydrane With Topical Drop Application

NCT04880928 | Completed Phase 4

• 1 other identifier: Mydriasis with Mydrane
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• subjective highest intraoperative pain

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

• subjective perception of anesthetic procedures

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

Study Arms (2)

injection solution

EXPERIMENTAL

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

Drug: Eye injection (Mydrane)

Standard eye Drops

ACTIVE COMPARATOR

Phenylephrine 10% and Tropicamid 0,5% eye drops

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

Interventions

Eye injection (Mydrane) DRUG

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

Also known as: Mydrane

injection solution

eye drops (Phenylephrin) DRUG

Phenylephrine 10%

Also known as: Minims

Standard eye Drops

eye drops (Tropicamid) DRUG

Tropicamid 0,5%

Also known as: Agepha

Standard eye Drops

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Cataract

Interventions

Injections, Intraocular; Ophthalmic Solutions; Tropicamide

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: August 12, 2020
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)