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Comparison Between Two Ss-OCT Biometry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333056
Recruitment Status : Completed
First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, 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.


Condition or disease Intervention/treatment
Cataract Senile 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.

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Comparison of Two Swept-Source Optical Coherence Tomography-based Biometry Devices
Actual Study Start Date : May 14, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : August 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract


Intervention Details:
  • Other: Biometric measurement agreement
    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 Outcome Measures :
  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




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The participants were selected by the clinical investigators at the Hanusch Hospital.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333056


Locations
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Austria
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, Austria, 1140
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
Investigators
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Principal Investigator: Oliver Findl, Prof., MD VIROS, Hanusch Hospital Vienna
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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Head of Ophthalmology Department, principal investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT04333056    
Other Study ID Numbers: ss-OCT biometry comparison
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery:
biometry
ss-OCT
cataract
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases