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Completed

NCT Number: NCT06358456

Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial tear

Drug

Application of low viscosity artificial tears (Artelac EDO). The active ingredient is hypromellose (1.92 mg per 0.6 ml container).

Other names: Artelac EDO

No artificial tears

Other

Before artificial tear application, 2 baseline measurements were taken of the cornea without any intervention

Primary outcomes

  1. 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)

    Time frame: 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 outcomes

  1. 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?

    Time frame: 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)

  2. 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)

    Time frame: 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)

  3. 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)?

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Clinic Frankfurt

Other

Registry information

Official study title

Influence of Artificial Tears on Corneal Parameter Measurement Using Three Different Devices: Scheimpflug-, Keratometry - and Placido-technology

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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