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

Sponsor

Medical University of Vienna (Other)

Overall Status

Unknown status

CT.gov ID

NCT04323358

Collaborator

(none)

Enrollment

Location

Arms

4.8

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cataract Cornea Surgery	Diagnostic Test: Biometry Diagnostic Test: Keratometry	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 5, 2020

Anticipated Primary Completion Date :

Jul 30, 2020

Anticipated Study Completion Date :

Jul 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Agreement of the four devices measuring mean keratometry value. [1 year]
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. [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. [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. [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 [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 [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 [1 year]
The measured white-to-white distance of each device and the measured white-to-white distance within one device will be compared

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 95 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna Allgemeines Krankenhaus	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Rupert Menapace, MD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rupert Menapace, Principal Investigator, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT04323358

Other Study ID Numbers:

1845/2019

First Posted:

Mar 26, 2020

Last Update Posted:

Mar 26, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Mar 26, 2020