Pupil diagnostics
Conditions
Interventions
Trade Name: Tropicamide
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: tropicamide
Other descriptive name: TROPICAMIDE
Concentration unit: % percent
Concentrati
Sponsors
St. Elisabeth Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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? ;Secondary Objective: Is there a subjective difference in the degree of physical discomfort, experienced after administration of a microdrop compared to a regular eyedrop? 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Physical discomfort, experienced after administration of a microdrop and a regular eyedrop. 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 | — |
Countries
Netherlands
Contacts
Public ContactSecretariaat Ziekenhuisapotheek
St. Elisabeth Ziekenhuis
Outcome results
None listed