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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| injection solution | Experimental | Mydrane, Tropicamid 0,02%, Phenylephrine 0,31%, Lidocain 1%, injection solution |
|
| Standard eye Drops | Active Comparator | Phenylephrine 10% and Tropicamid 0,5% eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye injection (Mydrane) | Drug | Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| subjective perception of anesthetic procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Graz | 8036 | Austria |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D009883 | Ophthalmic Solutions |
| D014331 | Tropicamide |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| eye drops (Phenylephrin) | Drug | Phenylephrine 10% |
|
|
| eye drops (Tropicamid) | Drug | Tropicamid 0,5% |
|
|
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 |
| D019999 |
| Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |