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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 30, 2020

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.

Interventions

  • Diagnostic Test: Biometry
    • 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.
  • Diagnostic Test: Keratometry
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: IOL Master® 700
    • Biometry will be performed three times consecutively.
  • Active Comparator: Pentacam®
    • Keratometry will be performed three times consecutively.
  • Active Comparator: Casia II®
    • Keratometry will be performed three times consecutively.
  • Active Comparator: Spectralis Anterion®
    • Biometry will be performed three times consecutively.

Clinical Trial Outcome Measures

Primary Measures

  • Agreement of the four devices measuring mean keratometry value.
    • Time Frame: 1 year
    • The measured K-Value of each device and the k-values within one device will be compared

Secondary Measures

  • Agreement of the four devices measuring mean steep keratometry value.
    • Time Frame: 1 year
    • 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.
    • Time Frame: 1 year
    • 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.
    • Time Frame: 1 year
    • 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
    • Time Frame: 1 year
    • 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
    • Time Frame: 1 year
    • 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
    • Time Frame: 1 year
    • The measured white-to-white distance of each device and the measured white-to-white distance within one device will be compared

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rupert Menapace, Principal Investigator – Medical University of Vienna
  • Overall Official(s)
    • Rupert Menapace, MD, Principal Investigator, Medical University of Vienna
  • Overall Contact(s)
    • Veronika Röggla, MD, 01 40400, veronika.roeggla@meduniwien.ac.at

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