E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Impact of selective alpha 1A receptor antagonists on the pupil size after instillation of tropicamide 0.5% and phenylephrine 10% |
Auswirkungen von selektive Alpha 1A Rezeptorantagonisten auf den Pupillendurchmesser nach dem Eintropfen der Pupille mit Tropicamide 0.5% und Phenylephrine 10% Augentropfen |
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E.1.1.1 | Medical condition in easily understood language |
Impact of selective alpha 1A receptor antagonists on the pupil size after instillation of tropicamide 0.5% and phenylephrine 10% |
Auswirkungen von selektive Alpha 1A Rezeptorantagonisten auf den Pupillendurchmesser nach dem Eintropfen der Pupille mit Tropicamide 0.5% und Phenylephrine 10% Augentropfen |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main outcome is to assess the pupil size before and after the instillation of tropicamide 0.5% and phenylephrine 10% eye drops between patients who are treated with tamsulosin and patients without a therapy of a systemic alpha 1A receptor antagonist. |
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E.2.2 | Secondary objectives of the trial |
Deflection of the iris during the operation under standardised conditions |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria for the study group - Age 21 and older - Age-related cataract - therapy with systemic selective alpha 1A antagonists (tamsulosin) - written informed consent to participation in the study
Inclusion criteria for the control group - Age 21 and older - Age-related cataract - written informed consent to participation in the study
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E.4 | Principal exclusion criteria |
Exclusion criteria for the study group - Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age) - Traumatic cataract - Any ophthalmic pathology that could compromise the measurements
Exclusion criteria for the control group - Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age) - Traumatic cataract - Any ophthalmic pathology that could compromise the measurements - Current or previous therapy with systemic alpha 1A antagonists
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E.5 End points |
E.5.1 | Primary end point(s) |
The pupil size before and after the instillation of tropicamide 0.5% and phenylephrine 10% eye drops between patients who are treated with tamsulosin and patients without a therapy of a systemic alpha 1A receptor antagonist. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
PREOP: - Auto Refraction - Subjective Refraction - Uncorrected visual acuity (UCDVA) - Best corrected visual acuity (BCDVA) - Intraocular pressure (IOP) - Slitlamp examination - Cataract Grading (LOCS) - Pupil size (baseline & 20 minutes after instillation of 1x drop tropicamide and 1xdrop phenylephrine)
INTRAOP: - IFIS grading (Grade 0 - 3) - Video recorded (yes/no) - Complications (yes/no)
POSTOP: - Slitlamp examination - Intraocular pressure (IOP) - 1h postOP IOP regulation (yes/no)
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E.5.2 | Secondary end point(s) |
Deflection of the iris during the operation under standardised conditions |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Intraoperative IFIS - Grading: - Grade 0 - Good dilatation, midriasis maintained - Grade 1 - Good initial dilatation, subsequent constriction - Grade 2 - Intermediate initial midriasis, subsequent constriction - Grade 3 - Poor dilatation from the beginning |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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1 hour after surgery of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |