Comparison Mydriasis by Mydrane With Topical Drop Application

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Drug: eye drops (Phenylephrin); Drug: eye drops (Tropicamid); Drug: Eye injection (Mydrane)

Study type: Interventional

Funder types: Other

Identifiers

NCT04880928

Mydriasis with Mydrane

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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42 participants in 2 patient groups

injection solution

Experimental group

Description:

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

Treatment:

Drug: Eye injection (Mydrane)

Standard eye Drops

Active Comparator group

Description:

Phenylephrine 10% and Tropicamid 0,5% eye drops

Treatment:

Drug: eye drops (Tropicamid)

Drug: eye drops (Phenylephrin)