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

Surgery Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cataract
• Cornea
• Surgery

• NCT number: NCT04323358
• Study type: Interventional
• Source: Medical University of Vienna
• Contact: Veronika Röggla, MD
• Phone: 01 40400
• Email: veronika.roeggla@meduniwien.ac.at
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2020
• Completion date: July 30, 2020