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

University Clinic Frankfurt145 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

145

Conditions

Healthy

Interventions

Artificial tearDRUG

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

No artificial tearsOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Goethe University Hospital

Frankfurt am Main, Hesse, Germany

Outcomes

Primary Outcomes

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)

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)

Time frame: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application

Secondary Outcomes

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?

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)

Time frame: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application

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)

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)

Time frame: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application

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)?

Data from ClinicalTrials.gov

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