patients who need a cataract surgery in both eyes
Conditions
Interventions
Trade Name: Mydrane, 0,2mg/ml + 3,1 mg/ml + 10 mg/ml Injektionslösung
Product Name: Mydrane, 0,2 mg/ml +3,1 mg/ml + 10 mg/ml Injektionslösung
Pharmaceutical Form: Injection
INN or Proposed INN: Lidoca
Sponsors
Medical University Graz, Department of Ophtalmology
Eligibility
Sex/Gender
All
Inclusion criteria
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: Pseudoexfolliation 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. tamsulosine) due to impeded mydriasis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
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 |
|---|---|
| Main Objective: 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.;Secondary Objective: Besides evaluating the pupil dilating effect another focus is put on intraoperative anesthesia. An intraindividual comparison by applying both methods on each patient (2 methods for 2 eyes) allows the interpretation of subjective perception by evaluating questionnaires following both surgical procedures. Patients are asked to mark their highest intraoperative pain and the subjective perception of anesthetic procedures (eye drops vs intracameral injection) on a visual analogue scale following both surgeries. Following the second surgery they are additionally asked to decide which method they would recommend to a relative. The steadiness of the dilated pupil is assessed by taking digital pictures allowing to measure the pupil diameter. These pictures are taken at predefined events of surgery: before capsulorhexis (T1), before lens implantation (T2) and before injection of cefuroxime, which means the end point of surgery (T3).;Primary end point(s): The frequency of the feasibility of capsulorhexis without additional pupil dilating actions.;Timepoint(s) of evaluation of this end point: end point at time of second surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Highest intraoperative pain visualized on a visual analogue scale (VAS) Subjectively more acceptable method, asked by a questionnaire Pupil diameter before capsulorhexis, before lens implantation and before injecting cefuroxime. ;Timepoint(s) of evaluation of this end point: end point at time of second surgery | — |
Countries
Austria
Contacts
Public ContactDepartment of Ophtalmology
Medical University of Graz
Outcome results
None listed