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Completed

NCT Number: NCT04333056

Comparison Between Two Ss-OCT Biometry

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.

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Key information

Conditions

Cataract Senile Cataract Eye Diseases Lens Diseases

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biometric measurement agreement

Other

Patients scheduled for cataract surgery were measured with both ss-OCT devices. The following biometry parameters were compared: anterior keratometry, central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT) and axial length (AL).

Primary outcomes

  1. Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters AL, ACD, LT (evaluated in mm)

    Time frame: 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

  2. Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters CCT (evaluated in micrometer)

    Time frame: 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

  3. Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameter: keratometry (evaluated in diopter)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2020
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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