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OpenTrials
Completed

NCT Number: NCT05411341

Comparison of Two Different Optical Biometric Systems

Primary objective of this study is to evaluate and compare the measurements of two different optical biometrics systems in patients who will undergo cataract surgery or presbyopia surgery using intraocular lenses (IOL-PC).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

About this study

This is a prospective study including patients visiting the outpatient Ophthalmology clinic of the University General Hospital of Alexandroupolis, who suffer from diagnosed cataract or presbyopia and are going to undergo implantation of intraocular lenses surgery. The patients will be fully informed about the procedure and the purpose of the study and a written informed consent will be provided by all participants. They will then undergo an ocular biometry examination using two optical biometric systems, Argos (Alcon Laboratories, Inc.) and IOLMaster 500 (Carl Zeiss Meditec AG). IOL Master 500 (Carl Zeiss Meditec AG) is a non-invasive optical biometer that uses partial coherence interferometry (PCI) with a wavelength of 780 nm to measure the AL of the eye. Argos (Alcon Laboratories, Inc.) is a novel non-invasive optical biometer that uses swept source optical coherence tomography (SS-OCT) with a wavelength of 1050 nm. The measurements of the two systems that will be compared are the axial length, the keratometry values, the anterior chamber depth (ACD), the horizontal corneal diameter (white to white [WTW]) and the lens power in diopters (D).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cataract and/or presbyopia who will undergo intraocular lens implantation.

Exclusion criteria

  • Dense cataract that does not allow measurements to be taken with an optical biometrics system.

Treatment and study plan

Argos (Alcon Laboratories, Inc.)

Device

An ocular biometry examination will be performed on the affected eyes using the Argos device.

IOLMaster 500 (Carl Zeiss Meditec AG)

Device

An ocular biometry examination will be performed on the affected eyes using the IOL Master 500 device.

Primary outcomes

  1. Axial length

    Time frame: 1 week

    The measurement of the axial length of the affected eye using both devices

  2. Keratometry values

    Time frame: 1 week

    The measurement of keratometry values K1: flat meridian of the anterior corneal surface and K2: steep meridian of the anterior corneal surface of the affected eye using both devices.

  3. Lens power (D)

    Time frame: 1 week

    The power of the lens is calculated by each device as a function of biometric measurements

Secondary outcomes

  1. Anterior chamber depth (ACD)

    Time frame: 1 week

    The measurement of the anterior chamber depth (ACD) of the affected eye using both devices.

  2. Horizontal corneal diameter (white to white [WTW])

    Time frame: 1 week

    The measurement of the horizontal corneal diameter of the affected eye using both devices.

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

Assessment of Two Different Optical Biometric Systems, Based on Different Optical Technologies in Patients With Cataract or Presbyopia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2022
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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