Back to resultsClinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients (KerSty)
Primary Purpose
Cataract, Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
High viscous artificial tears
Low viscous artificial tears
Sponsored by
About this trial
This is an interventional diagnostic trial for Cataract
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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High viscous artificial tears
Low viscous artificial tears
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT04196621
First Posted
December 5, 2019
Last Updated
April 27, 2020
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04196621
Brief Title
Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients
Acronym
KerSty
Official Title
Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
February 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Dry Eye
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High viscous artificial tears
Arm Type
Active Comparator
Arm Description
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
Arm Title
Low viscous artificial tears
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
High viscous artificial tears
Intervention Description
Instillation of one drop high viscous artificial tears
Intervention Type
Device
Intervention Name(s)
Low viscous artificial tears
Intervention Description
Instillation of one drop low viscous artificial tears
Primary Outcome Measure Information:
Title
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.
Description
The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
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.
Description
The change in measured k-values (k, k1, k2 in mm)before and after instillation of artificial eye drops will be calculated
Time Frame
2, 5minutes
Title
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
Description
The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated
Time Frame
30 seconds, 2 minutes or 5 minutes
Title
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
Description
The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated
Time Frame
30 seconds, 2 minutes or 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients
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