Clinical trial NCT04196621: Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients
Official title: Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Dry Eye
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 30 seconds
Secondary outcomes:
measure: 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.
timeFrame: 2, 5minutes
measure: 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
timeFrame: 30 seconds, 2 minutes or 5 minutes
measure: 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
timeFrame: 30 seconds, 2 minutes or 5 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: