The influence of dropsize of tropicamide eyedrops on pupildilatio
- Conditions
- Pupil diagnosticsTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2012-005219-18-NL
- Lead Sponsor
- St. Elisabeth Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
age between18-64 years
informed consent
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 28
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
eye disease, risk factors for angle-closure glaucoma, previous eyetrauma/surgery, dioptric value >+6, cardiac disease, diabetes, medication for the eye, medication influencing pupildiameter, substance abuse, (possible) pregnancy, breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Is the degree of pupildilation, achieved after administrating a 4.5 microliter microdrop tropicamide 0.5% equivalent to the pupildilation after a regular 30 microliter eydrop tropicamide 0.5% in healthy volunteers?<br><br>;Secondary Objective: Is there a subjective difference in the degree of physical discomfort, experienced after administration of a microdrop compared to a regular eyedrop?<br>Qualitative evaluation of the mydriatic reponse/time curves of both the microdrop and the regular eyedrop.;Primary end point(s): Within-subject pupildilation (compared to baseline) of a regular eyedrop and a microdrop at t=40 min.;Timepoint(s) of evaluation of this end point: 40 minutes after eyedrop administration
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Physical discomfort, experienced after administration of a microdrop and a regular eyedrop.<br>Qualitative evaluation of the mydriatic reponse/time curves of both the microdrop and the regular eyedrop.;Timepoint(s) of evaluation of this end point: following both studysessions