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Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract (Comparison)

Primary Purpose

Cataract, Cornea, Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Biometry
Keratometry
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cataract

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age-related cataract
  • Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)

Exclusion Criteria:

  • Contact lens wear within 5 days
  • Pathologic changes of the cornea, eye lid or conjunctiva on slit- lamp examination
  • History of corneal ocular surgery
  • Microphthalmus
  • Recurrent intraocular inflammation of unknown etiology
  • Blind fellow eye
  • Uncontrolled systemic or ocular disease

Sites / Locations

  • Medical University of Vienna Allgemeines KrankenhausRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

IOL Master® 700

Pentacam®

Casia II®

Spectralis Anterion®

Arm Description

Biometry will be performed three times consecutively.

Keratometry will be performed three times consecutively.

Keratometry will be performed three times consecutively.

Biometry will be performed three times consecutively.

Outcomes

Primary Outcome Measures

Agreement of the four devices measuring mean keratometry value.
The measured K-Value of each device and the k-values within one device will be compared

Secondary Outcome Measures

Agreement of the four devices measuring mean steep keratometry value.
The measured steep K-Value of each device and the steep k-values within one device will be compared
Agreement of the four devices measuring mean flat keratometry value.
The measured flat K-Value of each device and the flat k-values within one device will be compared
Agreement of the four devices measuring mean true keratometry value.
The measured true K-Value of each device and the true k-values within one device will be compared
Agreement of the devices measuring mean axial length
The measured axial length of each device and the axial length within one device will be compared
Agreement of the devices measuring mean lens thickness
The measured lens thickness of each device and the measured lens thickness within one device will be compared
Agreement of the devices measuring mean white-to-white measurement
The measured white-to-white distance of each device and the measured white-to-white distance within one device will be compared

Full Information

First Posted
March 17, 2020
Last Updated
March 24, 2020
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04323358
Brief Title
Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract
Acronym
Comparison
Official Title
Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)

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 rationale of this study is to compare repeatability, reproducibility and agreement of three different AS-OCT devices and Pentacam. The investigational devices are approved biometry and keratometry devices to perform biometric/keratometric measurements preoperatively before cataract surgery. The measurements are used to calculate the needed IOL power. Measurements with all four devices will be performed 3 times consecutively by two trained observer. The order of the observer, the order of devices as well as the eye (left/right) is randomized. Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry/keratometry with four different devices
Detailed Description
The rationale of this study is to compare repeatability, reproducibility and agreement of both, AS-OCT(s) and Pentacam. In our department three different AS-OCT devices and a HR Scheimpflug imaging device are currently in use for clinical routine to measure the cornea. Among refractive and anterior segment surgeons, there is no preferred and accepted method for accurate measurements of the corneal curvature. The four diagnostic tools are based on different technical and physical imaging principles and to date only limited information on their comparability exist. One advantage of ASOCT represents faster imaging speed when compared to Scheimpflug imaging. Thus, imaging misalignment, segmentation errors and defocus aberration can most likely be avoided by AS-OCT. Chen et al demonstrated that HR Scheimpflug imaging measurements of CCT were systematically higher than the measurements provided by FD AS-OCT. Further, repeatability, reproducibility and agreement of AS-OCT and Scheimpflug imaging device will be assessed during follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Cornea, Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Which eye as well as the order of devices and observer will be randomized. Randomization information will be put in a sealed envelope on screening date and opened right before measurements start.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IOL Master® 700
Arm Type
Active Comparator
Arm Description
Biometry will be performed three times consecutively.
Arm Title
Pentacam®
Arm Type
Active Comparator
Arm Description
Keratometry will be performed three times consecutively.
Arm Title
Casia II®
Arm Type
Active Comparator
Arm Description
Keratometry will be performed three times consecutively.
Arm Title
Spectralis Anterion®
Arm Type
Active Comparator
Arm Description
Biometry will be performed three times consecutively.
Intervention Type
Diagnostic Test
Intervention Name(s)
Biometry
Intervention Description
Patients will be asked to place the chin in position and open their eyes wide. In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
Intervention Type
Diagnostic Test
Intervention Name(s)
Keratometry
Intervention Description
Patients will be asked to place the chin in position and open their eyes wide. In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
Primary Outcome Measure Information:
Title
Agreement of the four devices measuring mean keratometry value.
Description
The measured K-Value of each device and the k-values within one device will be compared
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Agreement of the four devices measuring mean steep keratometry value.
Description
The measured steep K-Value of each device and the steep k-values within one device will be compared
Time Frame
1 year
Title
Agreement of the four devices measuring mean flat keratometry value.
Description
The measured flat K-Value of each device and the flat k-values within one device will be compared
Time Frame
1 year
Title
Agreement of the four devices measuring mean true keratometry value.
Description
The measured true K-Value of each device and the true k-values within one device will be compared
Time Frame
1 year
Title
Agreement of the devices measuring mean axial length
Description
The measured axial length of each device and the axial length within one device will be compared
Time Frame
1 year
Title
Agreement of the devices measuring mean lens thickness
Description
The measured lens thickness of each device and the measured lens thickness within one device will be compared
Time Frame
1 year
Title
Agreement of the devices measuring mean white-to-white measurement
Description
The measured white-to-white distance of each device and the measured white-to-white distance within one device will be compared
Time Frame
1 year

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: Age-related cataract Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible) Exclusion Criteria: Contact lens wear within 5 days Pathologic changes of the cornea, eye lid or conjunctiva on slit- lamp examination History of corneal ocular surgery Microphthalmus Recurrent intraocular inflammation of unknown etiology Blind fellow eye Uncontrolled systemic or ocular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronika Röggla, MD
Phone
01 40400
Ext
79450
Email
veronika.roeggla@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Leydolt, MD
Phone
01 40400
Ext
79480
Email
christina.leydolt@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupert Menapace, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna Allgemeines Krankenhaus
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupert Menapace, Prof.
Phone
014040066300
Email
rupert.menapace@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Christina Leydolt, MD
Phone
01 40400
Ext
79480
Email
christina.leydolt@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

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Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract

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