Comparison Mydriasis by Mydrane With Topical Drop Application

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880928
• Other study ID #: Mydriasis with Mydrane
• Status: Completed
• Phase: Phase 4
• Start date: August 12, 2020
• Est. completion date: September 23, 2021

Study information

• Verified date: October 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Mydriasis

Intervention

Drug:
• Eye injection (Mydrane)
Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride
• eye drops (Phenylephrin)
Phenylephrine 10%
• eye drops (Tropicamid)
Tropicamid 0,5%

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	after first and second surgery: a maximum of four weeks between first and second surgery
Secondary	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	after first and second surgery: a maximum of four weeks between first and second surgery