Effect of selective alpha 1A receptor antagonists on the iris dilator muscle
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 - Impending initiation of a therapy with systemic selective alpha 1A antagonists - written informed consent to participation in the study Inclusion criteria for the control group - Age 21 and older - 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 46 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) - previous therapy with systemic selective or non-selective alpha 1A antagonists - ophthalmic pathologies such as any ophthalmic pathologies or previous ocular surgeries Exclusion criteria for the control group - Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age) - previous therapy with systemic selective or non-selective alpha 1A antagonists - ophthalmic pathologies such as any ophthalmic pathologies or previous ocular surgeries
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Ratio between the iris dilator region muscle (DMR) and iris spincter region muscle (SMR) in patients taking selective alpha 1A antagonists and compare it with patients with no history of an intake of systemic alpha-1A antagonists after 1 year. ;Timepoint(s) of evaluation of this end point: PREOP: - Auto Refraction - Subjective Refraction - Uncorrected visual acuity (UCDVA) - Best corrected visual acuity (BCDVA) - Inraocula pressure (IOP) - Slitlamp examination - OCT measurment - Wasca Abberometer measurement 1 week: - OCT measurement 1 month / 3 month / 6 month / 1 year: - OCT measurement - Wasca Abberometer measurement - Uroflow measurment;Main Objective: The main outcome (ratio of DMR/SMR) is to assess ratio between the iris dilator region muscle and iris sphincter region muscle in patients taking selective alpha 1A antagonists and compare it with patients with no history of an intake of systemic alpha-1A antagonists. ;Secondary Objective: Decrease in thickness of DMR Comparison of DMR and SMR of the fellow eye | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: PREOP: - Auto Refraction - Subjective Refraction - Uncorrected visual acuity (UCDVA) - Best corrected visual acuity (BCDVA) - Inraocula pressure (IOP) - Slitlamp examination - OCT measurment - Wasca Abberometer measurement 1 week: - OCT measurement 1 month / 3 month / 6 month / 1 year: - OCT measurement - Wasca Abberometer measurement - Uroflow measurment;Secondary end point(s): Decrease in thickness of DMR Comparison of DMR and SMR of the fellow eye | — |
Countries
Austria
Contacts
Public ContactVIROS - Clinical Trial Information
Vienna Institute for Research in Ocular Surgery
Outcome results
None listed