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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2022-04-22

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one arm for each diagnostic device (three in total)

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

The investigator and patient knew which device they were tested on

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Artificial tear

Intervention Type DRUG

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

No artificial tears

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Artificial tear

Intervention Type DRUG

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

No artificial tears

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Artificial tear

Intervention Type DRUG

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

No artificial tears

Intervention Type OTHER

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

Interventions

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Artificial tear

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

Intervention Type DRUG

No artificial tears

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

Intervention Type OTHER

Other Intervention Names

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Artelac EDO

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes