Comparison Between Two Ss-OCT Biometry

Comparison of Two Swept-Source Optical Coherence Tomography-based Biometry Devices

Since recently a second swept-source optical coherence tomography (ss-OCT) optical biometry device was launched (Anterion, Heidelberg Engineering). Aim of this study is a retrospective data collection of patients who were measured with both ss-OCT optical biometry devices and to assess the limits of agreement of the two devices.

Retrospective comparison of two ss-OCT biometry devices concerning comparability of measurements of axial eye length, anterior chamber depth, lens thickness and keratometry.

Study Overview

• Status: Completed
• Conditions: Cataract Senile
• Intervention / Treatment: Other: Biometric measurement agreement

Detailed Description

This a retrospective study including data acquired from patients that attended pre-surgical examination as it is the standard in the investigator's hospital.

The IOL Master 700 (Carl Zeiss Meditec AG, Jena) and the Heidelberg Anterion (Heidelberg Engineering, Germany) are biometry devices that use swept-source optical coherence tomography technology in combination with a multidot-keratometer, that obtain two-dimensional images of ocular structures.

The difference between the two devices resides in the wavelength of the infrared laser: 1200-1400nm for the Anterion and 1050nm for the IOL Master 700.

The SS-OCT devices provide a scan depth of 44mm and a resolution in tissue of 22 μm for the IOL Master 700 and of 14x16.5 mm and 30 μm for the Heidelberg Anterion.

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Vienna Institute for Research in Ocular Surgery (VIROS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The participants were selected by the clinical investigators at the Hanusch Hospital.

Description

Inclusion Criteria:

• age-related cataract

Exclusion Criteria:

• nystagmus
• physical inabilities that could interfere with fixation
• dens cataract
• macular or corneal pathologies that could compromise fixation during the measurements.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters AL, ACD, LT (evaluated in mm)	For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution. The student T test for paired samples and Wilcoxon for nonparametric data was used to compare parameters as: AL, ACD, LT. The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs	6 months
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters CCT (evaluated in micrometer)	For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution. The student T test for paired samples and Wilcoxon for nonparametric data was used to compare the CCT data The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs	6 months
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameter: keratometry (evaluated in diopter)	For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution. The student T test for paired samples and Wilcoxon for nonparametric data was used to compare keratometry data The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs	6 months

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery
• Investigators: Principal Investigator: Oliver Findl, Prof., MD, VIROS, Hanusch Hospital Vienna

Publications and helpful links

General Publications

• Fisus AD, Hirnschall ND, Findl O. Comparison of 2 swept-source optical coherence tomography-based biometry devices. J Cataract Refract Surg. 2021 Jan 1;47(1):87-92. doi: 10.1097/j.jcrs.0000000000000373.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): August 12, 2019

Study Registration Dates

• First Submitted: March 28, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: cataract; ss-OCT; biometry
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ss-OCT biometry comparison

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
• product manufactured in and exported from the U.S.: No