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

Not Applicable

Completed

• Conditions: Cataract; Dry Eye
• Interventions: Device: Low viscous artificial tears; Device: High viscous artificial tears

• Registration Number: NCT04196621
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-12
• Primary Completion: 2019-12-31
• Study Completion: 2020-02-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low viscous artificial tears	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
High viscous artificial tears	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

Primary Outcome Measures

Name	Time	Method
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.	30 seconds	The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated

Secondary Outcome Measures

Name	Time	Method
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	30 seconds, 2 minutes or 5 minutes	The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated
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.	2, 5minutes	The change in measured k-values (k, k1, k2 in mm)before and after instillation of artificial eye drops will be calculated
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	30 seconds, 2 minutes or 5 minutes	The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria