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

April 7, 2024 updated by: Professor Dr. med. Thomas Kohnen, University Clinic Frankfurt

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hesse
      • Frankfurt, Hesse, Germany, 60590
        • Goethe University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IOL Master 700
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
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
Other: No artificial tears
Before artificial tear application, 2 baseline measurements were taken of the cornea without any intervention
Active Comparator: Pentacam AXL
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
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
Other: No artificial tears
Before artificial tear application, 2 baseline measurements were taken of the cornea without any intervention
Active Comparator: Galilei G6
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
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
Other: No artificial tears
Before artificial tear application, 2 baseline measurements were taken of the cornea without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)?
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
Comparison between the baseline measurements and the measurements up to 10 minutes after artificial tear applications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinic Frankfurt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Actual)

April 22, 2022

Study Completion (Actual)

April 22, 2022

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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