Impact of selective alpha 1A receptor antagonists on the pupil size after instillation of tropicamide 0.5% and phenylephrine 10%
Conditions
Sponsors
Vienna Institute for Research in Ocular Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Deflection of the iris during the operation under standardised conditions;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.;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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Deflection of the iris during the operation under standardised conditions;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 | — |
Countries
Austria
Contacts
Public ContactVIROS - Clinical Trial Information
Vienna Institute for Research in Ocular Surgery
Outcome results
None listed