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

NCT06358456 | Completed

• 1 other identifier: 20-928
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

artificial tears; keratometry; topography

Outcome Measures

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)

  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)

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

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

IOL Master 700

ACTIVE COMPARATOR

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

Drug: Artificial tear; Other: No artificial tears

Pentacam AXL

ACTIVE COMPARATOR

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

Drug: Artificial tear; Other: No artificial tears

Galilei G6

ACTIVE COMPARATOR

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

Drug: Artificial tear; Other: No artificial tears

Interventions

Artificial tear DRUG

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

Also known as: Artelac EDO

Galilei G6; IOL Master 700; Pentacam AXL

No artificial tears OTHER

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

Galilei G6; IOL Master 700; Pentacam AXL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy eyes

You may not qualify if:

• 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

Sponsors & Collaborators

• University Clinic Frankfurt: lead

Study Sites (1)

Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (1)

• 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.

  PMID: 32828877 BACKGROUND

MeSH Terms

Interventions

Lubricant Eye Drops

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The investigator and patient knew which device they were tested on
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Thomas Kohnen

Model Details: one arm for each diagnostic device (three in total)

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 10, 2024
• Study Start: November 20, 2020
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)