Clinical trial NCT04333056: Comparison Between Two Ss-OCT Biometry
Official title: Comparison of Two Swept-Source Optical Coherence Tomography-based Biometry Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Senile
Keywords: biometry
ss-OCT
cataract
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 210
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants were selected by the clinical investigators at the Hanusch Hospital.

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.

Eligibility 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.

Primary outcomes:
measure: Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters AL, ACD, LT (evaluated in mm)
timeFrame: 6 months
measure: Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters CCT (evaluated in micrometer)
timeFrame: 6 months
measure: Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameter: keratometry (evaluated in diopter)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS)
Study officials:
affiliation: VIROS, Hanusch Hospital Vienna
name: Oliver Findl, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.