Cataract
Conditions
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.
Interventions
DRUGEye injection (Mydrane)
Mydrane 0.2 mg/ml + 3.1 mg/ml \+ 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride
DRUGeye drops (Phenylephrin)
Phenylephrine 10%
Tropicamid 0,5%
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pupil dilating | 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
| Measure | Time frame | Description |
|---|---|---|
| subjective highest intraoperative pain | 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 |
| subjective perception of anesthetic procedures | 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 |
Countries
Austria
Outcome results
None listed