Comparison Between Two Ss-OCT Biometry

Cataract Senile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333056
• Other study ID #: ss-OCT biometry comparison
• Status: Completed
• Start date: May 14, 2019
• Est. completion date: August 12, 2019

Study information

• Verified date: March 2020
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: August 12, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

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).

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS)	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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