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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Artificial tear; Other: No artificial tears

• Registration Number: NCT06358456
• Lead Sponsor: University Clinic Frankfurt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-20
• Primary Completion: 2022-04-22
• Study Completion: 2022-04-22
• Study First Submitted: 2024-03-12
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-07
• Last Update Submitted: 2024-04-07
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentacam AXL	Artificial tear	Patients in this arm are measured twice with the Pentacam AXL without intervention. After this artificial tears are applied and followed by 4 more measurements
IOL Master 700	Artificial tear	Patients in this arm are measured twice with the IOL master 700 without intervention. After this artificial tears are applied and followed by 4 more measurements
IOL Master 700	No artificial tears	Patients in this arm are measured twice with the IOL master 700 without intervention. After this artificial tears are applied and followed by 4 more measurements
Galilei G6	Artificial tear	Patients in this arm are measured twice with the Galilei G6 without intervention. After this artificial tears are applied and followed by 4 more measurements
Galilei G6	No artificial tears	Patients in this arm are measured twice with the Galilei G6 without intervention. After this artificial tears are applied and followed by 4 more measurements
Pentacam AXL	No artificial tears	Patients in this arm are measured twice with the Pentacam AXL without intervention. After this artificial tears are applied and followed by 4 more measurements

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Goethe University Hospital; 🇩🇪 Frankfurt, Hesse, Germany