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

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-02-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Biometry will be performed in individuals with age related cataract. Patients will be classified as dry eye or normal eye. Two different artificial tears will be instilled at two time points in a randomized order with a time-lag of at least 24 hours.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Which eye as well as the order of artificial eye drops will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before procedure start.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

High viscous artificial tears

Intervention Type DEVICE

Instillation of one drop high 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

Group Type ACTIVE_COMPARATOR

Low viscous artificial tears

Intervention Type DEVICE

Instillation of one drop low viscous artificial tears

Interventions

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High viscous artificial tears

Instillation of one drop high viscous artificial tears

Intervention Type DEVICE

Low viscous artificial tears

Instillation of one drop low viscous artificial tears

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No