Comparison Between Two Ss-OCT Biometry

Completed

• Conditions: Cataract Senile

• Registration Number: NCT04333056
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

Brief Summary

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.

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 Timeline

• Study Start: 2019-05-14
• Primary Completion: 2019-07-31
• Study Completion: 2019-08-12
• Status Verified: 2020-03
• Study First Submitted: 2020-03-28
• Study First Submitted QC: 2020-04-02
• Last Update Submitted: 2020-04-02
• Study First Posted: 2020-04-03
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters AL, ACD, LT (evaluated in mm)	6 months	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
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters CCT (evaluated in micrometer)	6 months	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
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameter: keratometry (evaluated in diopter)	6 months	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

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS); 🇦🇹 Vienna, Austria