Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients (KerSty)

The investigational device is an approved biometry device to perform biometric measurements preoperatively to calculate the needed IOL power.

First, two native measurements at the IOL Master will be performed. Thereafter randomly assigned artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.

At least 24hours after those measurements, two native measurements at the IOL Master will be performed. Thereafter, the not yet used artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.

Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry without and with artificial tear drops.

Study Overview

• Status: Completed
• Conditions: Cataract; Dry Eye
• Intervention / Treatment: Device: High viscous artificial tears; Device: Low viscous artificial tears

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosed uni- or bilateral age-related cataract
• Age 40 to 95
• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

• Corneal abnormality (Corneal scaring)
• usage of artificial tears/eyedrops 24h before the examination
• necessity of any topical therapy of the eye (i.e. glaucoma)
• active ocular or nasal allergies or corneal or conjunctival infection
• abnormality of the nasolacrimal drainage apparatus
• dry eye severity level 4 (severe and/or disabling constant discomfort and visual symptoms, marked conjunctival injection, filamentary keratitis, mucus clumping, tear debris, ulceration, trichiasis, keratinization, symblepharon)
• lid deformities
• Preceding ocular surgery or trauma
• Pregnancy
• Lactation
• Uncontrolled systemic or ocular disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: High viscous artificial tears; First, a native measurement at the IOL Master will be performed. Following which, high viscous artificial tears are installed and the biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes	Device: High viscous artificial tears; Instillation of one drop high viscous artificial tears
ACTIVE_COMPARATOR: Low viscous artificial tears; First, a native measurement at the IOL Master will be performed. Following which, low viscous artificial tears are installed and the biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes	Device: Low viscous artificial tears; Instillation of one drop low viscous artificial tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary objective is to determine whether application of highly viscid eye drops in normal eyes leads to a change in keratometry measurements after 30 seconds.	The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated	30 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether application of highly viscid eye drops in normal eyes leads to a change keratometry measurements after 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective.	The change in measured k-values (k, k1, k2 in mm)before and after instillation of artificial eye drops will be calculated	2, 5minutes
To determine whether application of slightly viscid eye drops in normal and in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective	The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated	30 seconds, 2 minutes or 5 minutes
To determine whether application of highly viscid eye drops in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective	The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated	30 seconds, 2 minutes or 5 minutes

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): February 15, 2020

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (ACTUAL): December 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: 2112/2018

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