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Comparison of Three Swept-source Optical Coherence Biometry Devices in Long and Short Eyes

NCT05232214 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2022-10-17

No results posted yet for this study

Summary

The aim of the study is to compare the agreement and repeatability of ocular biometric parameters obtained using three swept-source optical coherence tomography (ss-OCT) device (Argos, IOLMaster 700 and ANTERION).

This is a prospective, single centre study, that would include a number of 50 eyes of 50 patients, which attend pre-surgical examination. Three measurements per biometry device will be performed on the day of the first eye surgery. The measurements will be performed in a randomised fashion with three ss-OCT devices (IOLMaster 700, Argos and ANTERION).

Inclusion criteria are: 40 years or above, age-related cataract, 20 eyes with AL\< 22.0 mm and 30 eyes with AL\>25.5 mm.

Exclusion criteria are: patients with ocular or systemic pathologies that would interfere with the measurements (e.g. dense cataract, corneal pathology, nystagmus).

The main outcome of the study will be: the difference (Limits of agreement) between the devices for the following parameters: keratometry (Ks, Kf, Km), CCT (µm), ACD (mm), LT (mm), AL (mm). Secondary outcomes will be: repeatability coefficient and coefficient of variation between the three device, measurement time for each device, and the feasibility for the Argos device.

Conditions

  • Cataract

Interventions

DEVICE

Biometry

Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Argos and Anterion Heildelberg). Each patient will be measured three times with each device

Sponsors & Collaborators

  • Vienna Institute for Research in Ocular Surgery

    lead OTHER

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-08-01
Completion
2023-10-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05232214 on ClinicalTrials.gov