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

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 Overview

• Status: Unknown
• Conditions: Cataract; Surgery; Cornea
• Intervention / Treatment: Diagnostic test: Biometry; Diagnostic test: Keratometry

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronika Röggla, MD; Phone Number: 79450 01 40400; Email: veronika.roeggla@meduniwien.ac.at
• Study Contact Backup: Name: Christina Leydolt, MD; Phone Number: 79480 01 40400; Email: christina.leydolt@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna Allgemeines Krankenhaus
    • Contact: Rupert Menapace, Prof.; Phone Number: 014040066300; Email: rupert.menapace@meduniwien.ac.at
    • Contact: Christina Leydolt, MD; Phone Number: 79480 01 40400; Email: christina.leydolt@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IOL Master® 700; Biometry will be performed three times consecutively.	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.
Active Comparator: Pentacam®; Keratometry will be performed three times consecutively.	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.
Active Comparator: Casia II®; Keratometry will be performed three times consecutively.	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.
Active Comparator: Spectralis Anterion®; Biometry will be performed three times consecutively.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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	1 year
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	1 year
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	1 year
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	1 year
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	1 year

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Rupert Menapace, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 1845/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No