Clinical trial NCT06358456: Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices
Official title: Influence of Artificial Tears on Corneal Parameter Measurement Using Three Different Devices: Scheimpflug-, Keratometry - and Placido-technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: artificial tears
keratometry
topography
Lead sponsor: University Clinic Frankfurt
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one arm for each diagnostic device (three in total)
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
Secondary outcomes:
measure: 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?
timeFrame: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
measure: 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)
timeFrame: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
measure: 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)?
timeFrame: Comparison between the baseline measurements and the measurements up to 10 minutes after artificial tear applications
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University Hospital
state: Hesse
Study officials:
References:
citation: Roggla V, Leydolt C, Schartmuller D, Schwarzenbacher L, Meyer E, Abela-Formanek C, Menapace R. Influence of Artificial Tears on Keratometric Measurements in Cataract Patients. Am J Ophthalmol. 2021 Jan;221:1-8. doi: 10.1016/j.ajo.2020.08.024. Epub 2020 Aug 21.