Healthy
Conditions
Keywords
artificial tears, keratometry, topography
Brief summary
The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are: * Do artificial tears alter the measurements of the corneal surface * Is there a difference between the devices used in this study This is relevant because high quality measurements improve the postoperative outcome after cataract surgery.
Interventions
DRUGArtificial tear
Application of low viscosity artificial tears (Artelac EDO). The active ingredient is hypromellose (1.92 mg per 0.6 ml container).
OTHERNo artificial tears
Before artificial tear application, 2 baseline measurements were taken of the cornea without any intervention
Sponsors
University Clinic Frankfurt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The investigator and patient knew which device they were tested on
Intervention model description
one arm for each diagnostic device (three in total)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy eyes
Exclusion criteria
* Any prior intraocular surgery or trauma * Any corneal pathology (ABMD, Fuch's, etc.) * Active ocular pathology (e.g., amblyopia, ARMD) * Contact lens wear within 2 weeks of study * Any corneal relaxing incisions or astigmatic keratotomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) | Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application | Difference of measurement of the mean corneal refractive power in diopters before artificial tear application and after artificial tear application using one of three devices (IOL Master 700, Pentacam AXL or Galilei G6) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application? | Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application | Difference of measurement of the mean corneal refractive power in diopters before artificial tear (Artelac EDO) application and after artificial tear application between the three devices (IOL Master 700 using Keratometry, Pentacam AXL and Galilei G6 using Schmeipflug technology) |
| Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) | Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application | Difference of measurement of the mean corneal astigmatism in diopters before artificial tear (Artelac EDO) application and after artificial tear application using three different devices (IOL Master 700, Pentacam AXL and Galilei G6) |
| If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)? | Comparison between the baseline measurements and the measurements up to 10 minutes after artificial tear applications | How long does the difference of mean corneal refractive power in diopters before artificial tear (artelac ego) application and after artificial tear application last |
Countries
Germany
Outcome results
None listed