Comparison Between Two Ss-OCT Biometry

NCT ID: NCT04333056

Last Updated: 2020-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-14

Study Completion Date

2019-08-12

Brief Summary

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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

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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.

Conditions

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Cataract Senile

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Head of Ophthalmology Department, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Findl, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

VIROS, Hanusch Hospital Vienna

Locations

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Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 32769752 (View on PubMed)

Other Identifiers

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ss-OCT biometry comparison

Identifier Type: -

Identifier Source: org_study_id

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